Seal-forming structure, positioning and stabilizing structure and diffuser vent for patient interface

ABSTRACT

A patient interface to deliver a flow of air at a positive pressure with respect to ambient air pressure to an entrance to the patient&#39;s airways to ameliorate sleep disordered breathing includes a frame assembly and a cushion assembly configured to removably and repeatably connect to the frame assembly. The frame assembly and the cushion assembly form at least part of a plenum chamber pressurizable to a therapeutic pressure. The cushion assembly comprises a one-piece construction including a seal-forming structure configured to form a seal with a region of a patients face surrounding the entrance to the patients airways and a frame connection structure configured to removably and repeatably connect the cushion assembly to the frame assembly. The seal-forming structure comprises a first elastomeric material and the frame connection structure comprises a second elastomeric material, the first elastomeric material comprising a lower durometer or hardness than the second elastomeric material.

1. CROSS-REFERENCE TO RELATED APPLICATIONS

This application is the U.S. national phase of International ApplicationNo. PCT/IB2020/053311 filed Apr. 7, 2020 which designated the U.S. andclaims priority to U.S. Provisional Application No. 62/830,745 filedApr. 8, 2019 and U.S. Provisional Application No. 62/830,764 filed Apr.8, 2019, the entire contents of each of which are hereby incorporated byreference.

A portion of the disclosure of this patent document contains materialwhich is subject to copyright protection. The copyright owner has noobjection to the facsimile reproduction by anyone of the patent documentor the patent disclosure, as it appears in Patent Office patent files orrecords, but otherwise reserves all copyright rights whatsoever.

2. BACKGROUND OF THE TECHNOLOGY 2.1 Field of the Technology

The present technology relates to one or more of the screening,diagnosis, monitoring, treatment, prevention and amelioration ofrespiratory-related disorders. The present technology also relates tomedical devices or apparatus, and their use.

2.2 Description of the Related Art

2.2.1 Human Respiratory System and its Disorders

The respiratory system of the body facilitates gas exchange. The noseand mouth form the entrance to the airways of a patient.

The airways include a series of branching tubes, which become narrower,shorter and more numerous as they penetrate deeper into the lung. Theprime function of the lung is gas exchange, allowing oxygen to move fromthe inhaled air into the venous blood and carbon dioxide to move in theopposite direction. The trachea divides into right and left mainbronchi, which further divide eventually into terminal bronchioles. Thebronchi make up the conducting airways, and do not take part in gasexchange. Further divisions of the airways lead to the respiratorybronchioles, and eventually to the alveoli. The alveolated region of thelung is where the gas exchange takes place, and is referred to as therespiratory zone. See “Respiratory Physiology”, by John B. West,Lippincott Williams & Wilkins, 9th edition published 2012.

A range of respiratory disorders exist. Certain disorders may becharacterised by particular events, e.g. apneas, hypopneas, andhyperpneas.

Examples of respiratory disorders include Obstructive Sleep Apnea (OSA),Cheyne-Stokes Respiration (CSR), respiratory insufficiency, ObesityHyperventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease(COPD), Neuromuscular Disease (NMD) and Chest wall disorders.

Obstructive Sleep Apnea (OSA), a form of Sleep Disordered Breathing(SDB), is characterised by events including occlusion or obstruction ofthe upper air passage during sleep. It results from a combination of anabnormally small upper airway and the normal loss of muscle tone in theregion of the tongue, soft palate and posterior oropharyngeal wallduring sleep. The condition causes the affected patient to stopbreathing for periods typically of 30 to 120 seconds in duration,sometimes 200 to 300 times per night. It often causes excessive daytimesomnolence, and it may cause cardiovascular disease and brain damage.The syndrome is a common disorder, particularly in middle agedoverweight males, although a person affected may have no awareness ofthe problem. See U.S. Pat. No. 4,944,310 (Sullivan).

Cheyne-Stokes Respiration (CSR) is another form of sleep disorderedbreathing. CSR is a disorder of a patient's respiratory controller inwhich there are rhythmic alternating periods of waxing and waningventilation known as CSR cycles. CSR is characterised by repetitivede-oxygenation and re-oxygenation of the arterial blood. It is possiblethat CSR is harmful because of the repetitive hypoxia. In some patientsCSR is associated with repetitive arousal from sleep, which causessevere sleep disruption, increased sympathetic activity, and increasedafterload. See U.S. Pat. No. 6,532,959 (Berthon-Jones).

Respiratory failure is an umbrella term for respiratory disorders inwhich the lungs are unable to inspire sufficient oxygen or exhalesufficient CO₂ to meet the patient's needs. Respiratory failure mayencompass some or all of the following disorders.

A patient with respiratory insufficiency (a form of respiratory failure)may experience abnormal shortness of breath on exercise.

Obesity Hyperventilation Syndrome (OHS) is defined as the combination ofsevere obesity and awake chronic hypercapnia, in the absence of otherknown causes for hypoventilation. Symptoms include dyspnea, morningheadache and excessive daytime sleepiness.

Chronic Obstructive Pulmonary Disease (COPD) encompasses any of a groupof lower airway diseases that have certain characteristics in common.These include increased resistance to air movement, extended expiratoryphase of respiration, and loss of the normal elasticity of the lung.Examples of COPD are emphysema and chronic bronchitis. COPD is caused bychronic tobacco smoking (primary risk factor), occupational exposures,air pollution and genetic factors. Symptoms include: dyspnea onexertion, chronic cough and sputum production.

Neuromuscular Disease (NMD) is a broad term that encompasses manydiseases and ailments that impair the functioning of the muscles eitherdirectly via intrinsic muscle pathology, or indirectly via nervepathology. Some NMD patients are characterised by progressive muscularimpairment leading to loss of ambulation, being wheelchair-bound,swallowing difficulties, respiratory muscle weakness and, eventually,death from respiratory failure. Neuromuscular disorders can be dividedinto rapidly progressive and slowly progressive: (i) Rapidly progressivedisorders: Characterised by muscle impairment that worsens over monthsand results in death within a few years (e.g. Amyotrophic lateralsclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers);(ii) Variable or slowly progressive disorders: Characterised by muscleimpairment that worsens over years and only mildly reduces lifeexpectancy (e.g. Limb girdle, Facioscapulohumeral and Myotonic musculardystrophy). Symptoms of respiratory failure in NMD include: increasinggeneralised weakness, dysphagia, dyspnea on exertion and at rest,fatigue, sleepiness, morning headache, and difficulties withconcentration and mood changes.

Chest wall disorders are a group of thoracic deformities that result ininefficient coupling between the respiratory muscles and the thoraciccage. The disorders are usually characterised by a restrictive defectand share the potential of long term hypercapnic respiratory failure.Scoliosis and/or kyphoscoliosis may cause severe respiratory failure.Symptoms of respiratory failure include: dyspnea on exertion, peripheraloedema, orthopnea, repeated chest infections, morning headaches,fatigue, poor sleep quality and loss of appetite.

A range of therapies have been used to treat or ameliorate suchconditions. Furthermore, otherwise healthy individuals may takeadvantage of such therapies to prevent respiratory disorders fromarising. However, these have a number of shortcomings.

2.2.2 Therapy

Various therapies, such as Continuous Positive Airway Pressure (CPAP)therapy, Non-invasive ventilation (NIV) and Invasive ventilation (IV)have been used to treat one or more of the above respiratory disorders.

Continuous Positive Airway Pressure (CPAP) therapy has been used totreat Obstructive Sleep Apnea (OSA). The mechanism of action is thatcontinuous positive airway pressure acts as a pneumatic splint and mayprevent upper airway occlusion, such as by pushing the soft palate andtongue forward and away from the posterior oropharyngeal wall. Treatmentof OSA by CPAP therapy may be voluntary, and hence patients may electnot to comply with therapy if they find devices used to provide suchtherapy one or more of: uncomfortable, difficult to use, expensive andaesthetically unappealing.

Non-invasive ventilation (NIV) provides ventilatory support to a patientthrough the upper airways to assist the patient breathing and/ormaintain adequate oxygen levels in the body by doing some or all of thework of breathing. The ventilatory support is provided via anon-invasive patient interface. NIV has been used to treat CSR andrespiratory failure, in forms such as OHS, COPD, NMD and Chest Walldisorders. In some forms, the comfort and effectiveness of thesetherapies may be improved.

Invasive ventilation (IV) provides ventilatory support to patients thatare no longer able to effectively breathe themselves and may be providedusing a tracheostomy tube. In some forms, the comfort and effectivenessof these therapies may be improved.

2.2.3 Treatment Systems

These therapies may be provided by a treatment system or device. Suchsystems and devices may also be used to screen, diagnose, or monitor acondition without treating it.

A treatment system may comprise a Respiratory Pressure Therapy Device(RPT device), an air circuit, a humidifier, a patient interface, anddata management.

Another form of treatment system is a mandibular repositioning device.

2.2.3.1 Patient Interface

A patient interface may be used to interface respiratory equipment toits wearer, for example by providing a flow of air to an entrance to theairways. The flow of air may be provided via a mask to the nose and/ormouth, a tube to the mouth or a tracheostomy tube to the trachea of apatient. Depending upon the therapy to be applied, the patient interfacemay form a seal, e.g., with a region of the patient's face, tofacilitate the delivery of gas at a pressure at sufficient variance withambient pressure to effect therapy, e.g., at a positive pressure ofabout 10 cmH₂O relative to ambient pressure. For other forms of therapy,such as the delivery of oxygen, the patient interface may not include aseal sufficient to facilitate delivery to the airways of a supply of gasat a positive pressure of about 10 cmH₂O.

Certain other mask systems may be functionally unsuitable for thepresent field. For example, purely ornamental masks may be unable tomaintain a suitable pressure. Mask systems used for underwater swimmingor diving may be configured to guard against ingress of water from anexternal higher pressure, but not to maintain air internally at a higherpressure than ambient.

Certain masks may be clinically unfavourable for the present technologye.g. if they block airflow via the nose and only allow it via the mouth.

Certain masks may be uncomfortable or impractical for the presenttechnology if they require a patient to insert a portion of a maskstructure in their mouth to create and maintain a seal via their lips.

Certain masks may be impractical for use while sleeping, e.g. forsleeping while lying on one's side in bed with a head on a pillow.

The design of a patient interface presents a number of challenges. Theface has a complex three-dimensional shape. The size and shape of nosesand heads varies considerably between individuals. Since the headincludes bone, cartilage and soft tissue, different regions of the facerespond differently to mechanical forces. The jaw or mandible may moverelative to other bones of the skull. The whole head may move during thecourse of a period of respiratory therapy.

As a consequence of these challenges, some masks suffer from being oneor more of obtrusive, aesthetically undesirable, costly, poorly fitting,difficult to use, and uncomfortable especially when worn for longperiods of time or when a patient is unfamiliar with a system. Wronglysized masks can give rise to reduced compliance, reduced comfort andpoorer patient outcomes. Masks designed solely for aviators, masksdesigned as part of personal protection equipment (e.g. filter masks),SCUBA masks, or for the administration of anaesthetics may be tolerablefor their original application, but nevertheless such masks may beundesirably uncomfortable to be worn for extended periods of time, e.g.,several hours. This discomfort may lead to a reduction in patientcompliance with therapy. This is even more so if the mask is to be wornduring sleep.

CPAP therapy is highly effective to treat certain respiratory disorders,provided patients comply with therapy. If a mask is uncomfortable, ordifficult to use a patient may not comply with therapy. Since it isoften recommended that a patient regularly wash their mask, if a mask isdifficult to clean (e.g., difficult to assemble or disassemble),patients may not clean their mask and this may impact on patientcompliance.

While a mask for other applications (e.g. aviators) may not be suitablefor use in treating sleep disordered breathing, a mask designed for usein treating sleep disordered breathing may be suitable for otherapplications.

For these reasons, patient interfaces for delivery of CPAP during sleepform a distinct field.

2.2.3.1.1 Seal-Forming Structure

Patient interfaces may include a seal-forming structure. Since it is indirect contact with the patient's face, the shape and configuration ofthe seal-forming structure can have a direct impact the effectivenessand comfort of the patient interface.

A patient interface may be partly characterised according to the designintent of where the seal-forming structure is to engage with the face inuse. In one form of patient interface, a seal-forming structure maycomprise a first sub-portion to form a seal around the left naris and asecond sub-portion to form a seal around the right naris. In one form ofpatient interface, a seal-forming structure may comprise a singleelement that surrounds both nares in use. Such single element may bedesigned to for example overlay an upper lip region and a nasal bridgeregion of a face. In one form of patient interface a seal-formingstructure may comprise an element that surrounds a mouth region in use,e.g. by forming a seal on a lower lip region of a face. In one form ofpatient interface, a seal-forming structure may comprise a singleelement that surrounds both nares and a mouth region in use. Thesedifferent types of patient interfaces may be known by a variety of namesby their manufacturer including nasal masks, full-face masks, nasalpillows, nasal puffs and oro-nasal masks.

A seal-forming structure that may be effective in one region of apatient's face may be inappropriate in another region, e.g. because ofthe different shape, structure, variability and sensitivity regions ofthe patient's face. For example, a seal on swimming goggles thatoverlays a patient's forehead may not be appropriate to use on apatient's nose.

Certain seal-forming structures may be designed for mass manufacturesuch that one design fit and be comfortable and effective for a widerange of different face shapes and sizes. To the extent to which thereis a mismatch between the shape of the patient's face, and theseal-forming structure of the mass-manufactured patient interface, oneor both must adapt in order for a seal to form.

One type of seal-forming structure extends around the periphery of thepatient interface, and is intended to seal against the patient's facewhen force is applied to the patient interface with the seal-formingstructure in confronting engagement with the patient's face. Theseal-forming structure may include an air or fluid filled cushion, or amoulded or formed surface of a resilient seal element made of anelastomer such as a rubber. With this type of seal-forming structure, ifthe fit is not adequate, there will be gaps between the seal-formingstructure and the face, and additional force will be required to forcethe patient interface against the face in order to achieve a seal.

Another type of seal-forming structure incorporates a flap seal of thinmaterial positioned about the periphery of the mask so as to provide aself-sealing action against the face of the patient when positivepressure is applied within the mask. Like the previous style of sealforming portion, if the match between the face and the mask is not good,additional force may be required to achieve a seal, or the mask mayleak. Furthermore, if the shape of the seal-forming structure does notmatch that of the patient, it may crease or buckle in use, giving riseto leaks.

Another type of seal-forming structure may comprise a friction-fitelement, e.g. for insertion into a naris, however some patients findthese uncomfortable.

Another form of seal-forming structure may use adhesive to achieve aseal. Some patients may find it inconvenient to constantly apply andremove an adhesive to their face.

A range of patient interface seal-forming structure technologies aredisclosed in the following patent applications, assigned to ResMedLimited: WO 1998/004,310; WO 2006/074,513; WO 2010/135,785.

One form of nasal pillow is found in the Adam Circuit manufactured byPuritan Bennett. Another nasal pillow, or nasal puff is the subject ofU.S. Pat. No. 4,782,832 (Trimble et al.), assigned to Puritan-BennettCorporation.

ResMed Limited has manufactured the following products that incorporatenasal pillows: SWIFT™ nasal pillows mask, SWIFT™ II nasal pillows mask,SWIFT™ LT nasal pillows mask, SWIFT™ FX nasal pillows mask and MIRAGELIBERTY™ full-face mask. The following patent applications, assigned toResMed Limited, describe examples of nasal pillows masks: InternationalPatent Application WO2004/073,778 (describing amongst other thingsaspects of the ResMed Limited SWIFT™ nasal pillows), US PatentApplication 2009/0044808 (describing amongst other things aspects of theResMed Limited SWIFT™ LT nasal pillows); International PatentApplications WO 2005/063,328 and WO 2006/130,903 (describing amongstother things aspects of the ResMed Limited MIRAGE LIBERTY™ full-facemask); International Patent Application WO 2009/052,560 (describingamongst other things aspects of the ResMed Limited SWIFT™ FX nasalpillows).

2.2.3.1.2 Positioning and Stabilising

A seal-forming structure of a patient interface used for positive airpressure therapy is subject to the corresponding force of the airpressure to disrupt a seal. Thus a variety of techniques have been usedto position the seal-forming structure, and to maintain it in sealingrelation with the appropriate portion of the face.

One technique is the use of adhesives. See for example US PatentApplication Publication No. US 2010/0000534. However, the use ofadhesives may be uncomfortable for some.

Another technique is the use of one or more straps and/or stabilisingharnesses. Many such harnesses suffer from being one or more ofill-fitting, bulky, uncomfortable and awkward to use.

2.2.3.2 Respiratory Pressure Therapy (RPT) Device

A respiratory pressure therapy (RPT) device may be used individually oras part of a system to deliver one or more of a number of therapiesdescribed above, such as by operating the device to generate a flow ofair for delivery to an interface to the airways. The flow of air may bepressurised. Examples of RPT devices include a CPAP device and aventilator.

Air pressure generators are known in a range of applications, e.g.industrial-scale ventilation systems. However, air pressure generatorsfor medical applications have particular requirements not fulfilled bymore generalised air pressure generators, such as the reliability, sizeand weight requirements of medical devices. In addition, even devicesdesigned for medical treatment may suffer from shortcomings, pertainingto one or more of: comfort, noise, ease of use, efficacy, size, weight,manufacturability, cost, and reliability.

An example of the special requirements of certain RPT devices isacoustic noise.

Table of noise output levels of prior RPT devices (one specimen only,measured using test method specified in ISO 3744 in CPAP mode at 10cmH₂O).

A-weighted sound pressure level Year RPT Device name dB(A) (approx.)C-Series Tango ™ 31.9 2007 C-Series Tango ™ with Humidifier 33.1 2007 S8Escape ™ II 30.5 2005 S8 Escape ™ II with H4i ™ Humidifier 31.1 2005 S9AutoSet ™ 26.5 2010 S9 AutoSet ™ with H5i Humidifier 28.6 2010

One known RPT device used for treating sleep disordered breathing is theS9 Sleep Therapy System, manufactured by ResMed Limited. Another exampleof an RPT device is a ventilator. Ventilators such as the ResMedStellar™ Series of Adult and Paediatric Ventilators may provide supportfor invasive and non-invasive non-dependent ventilation for a range ofpatients for treating a number of conditions such as but not limited toNMD, OHS and COPD.

The ResMed Elisée™ 150 ventilator and ResMed VS III™ ventilator mayprovide support for invasive and non-invasive dependent ventilationsuitable for adult or paediatric patients for treating a number ofconditions. These ventilators provide volumetric and barometricventilation modes with a single or double limb circuit. RPT devicestypically comprise a pressure generator, such as a motor-driven bloweror a compressed gas reservoir, and are configured to supply a flow ofair to the airway of a patient. In some cases, the flow of air may besupplied to the airway of the patient at positive pressure. The outletof the RPT device is connected via an air circuit to a patient interfacesuch as those described above.

The designer of a device may be presented with an infinite number ofchoices to make Design criteria often conflict, meaning that certaindesign choices are far from routine or inevitable. Furthermore, thecomfort and efficacy of certain aspects may be highly sensitive tosmall, subtle changes in one or more parameters.

2.2.3.3 Humidifier

Delivery of a flow of air without humidification may cause drying ofairways. The use of a humidifier with an RPT device and the patientinterface produces humidified gas that minimizes drying of the nasalmucosa and increases patient airway comfort. In addition in coolerclimates, warm air applied generally to the face area in and about thepatient interface is more comfortable than cold air.

A range of artificial humidification devices and systems are known,however they may not fulfil the specialised requirements of a medicalhumidifier.

Medical humidifiers are used to increase humidity and/or temperature ofthe flow of air in relation to ambient air when required, typicallywhere the patient may be asleep or resting (e.g. at a hospital). Amedical humidifier for bedside placement may be small A medicalhumidifier may be configured to only humidify and/or heat the flow ofair delivered to the patient without humidifying and/or heating thepatient's surroundings. Room-based systems (e.g. a sauna, an airconditioner, or an evaporative cooler), for example, may also humidifyair that is breathed in by the patient, however those systems would alsohumidify and/or heat the entire room, which may cause discomfort to theoccupants. Furthermore medical humidifiers may have more stringentsafety constraints than industrial humidifiers

While a number of medical humidifiers are known, they can suffer fromone or more shortcomings. Some medical humidifiers may provideinadequate humidification, some are difficult or inconvenient to use bypatients.

2.2.3.4 Data Management

There may be clinical reasons to obtain data to determine whether thepatient prescribed with respiratory therapy has been “compliant”, e.g.that the patient has used their RPT device according to one or more“compliance rules”. One example of a compliance rule for CPAP therapy isthat a patient, in order to be deemed compliant, is required to use theRPT device for at least four hours a night for at least 21 of 30consecutive days. In order to determine a patient's compliance, aprovider of the RPT device, such as a health care provider, may manuallyobtain data describing the patient's therapy using the RPT device,calculate the usage over a predetermined time period, and compare withthe compliance rule. Once the health care provider has determined thatthe patient has used their RPT device according to the compliance rule,the health care provider may notify a third party that the patient iscompliant.

There may be other aspects of a patient's therapy that would benefitfrom communication of therapy data to a third party or external system.

Existing processes to communicate and manage such data can be one ormore of costly, time-consuming, and error-prone.

2.2.3.5 Mandibular Repositioning

A mandibular repositioning device (MRD) or mandibular advancement device(MAD) is one of the treatment options for sleep apnea and snoring. It isan adjustable oral appliance available from a dentist or other supplierthat holds the lower jaw (mandible) in a forward position during sleep.The MRD is a removable device that a patient inserts into their mouthprior to going to sleep and removes following sleep. Thus, the MRD isnot designed to be worn all of the time. The MRD may be custom made orproduced in a standard form and includes a bite impression portiondesigned to allow fitting to a patient's teeth. This mechanicalprotrusion of the lower jaw expands the space behind the tongue, putstension on the pharyngeal walls to reduce collapse of the airway anddiminishes palate vibration.

In certain examples a mandibular advancement device may comprise anupper splint that is intended to engage with or fit over teeth on theupper jaw or maxilla and a lower splint that is intended to engage withor fit over teeth on the upper jaw or mandible. The upper and lowersplints are connected together laterally via a pair of connecting rods.The pair of connecting rods are fixed symmetrically on the upper splintand on the lower splint.

In such a design the length of the connecting rods is selected such thatwhen the MRD is placed in a patient's mouth the mandible is held in anadvanced position. The length of the connecting rods may be adjusted tochange the level of protrusion of the mandible. A dentist may determinea level of protrusion for the mandible that will determine the length ofthe connecting rods.

Some MRDs are structured to push the mandible forward relative to themaxilla while other MADs, such as the ResMed Narval CC™ MRD are designedto retain the mandible in a forward position. This device also reducesor minimises dental and temporo-mandibular joint (TMJ) side effects.Thus, it is configured to minimises or prevent any movement of one ormore of the teeth.

2.2.3.6 Vent Technologies

Some forms of treatment systems may include a vent to allow the washoutof exhaled carbon dioxide. The vent may allow a flow of gas from aninterior space of a patient interface, e.g., the plenum chamber, to anexterior of the patient interface, e.g., to ambient.

The vent may comprise an orifice and gas may flow through the orifice inuse of the mask. Many such vents are noisy. Others may become blocked inuse and thus provide insufficient washout. Some vents may be disruptiveof the sleep of a bed partner 1100 of the patient 1000, e.g. throughnoise or focussed airflow.

ResMed Limited has developed a number of improved mask venttechnologies. See International Patent Application Publication No. WO1998/034,665; International Patent Application Publication No. WO2000/078,381; U.S. Pat. No. 6,581,594; US Patent Application PublicationNo. US 2009/0050156; US Patent Application Publication No. 2009/0044808.

Table of noise of prior masks (ISO 17510-2:2007, 10 cmH₂O pressure at 1m)

A-weighted A-weighted sound power sound pressure Mask Mask level dB(A)dB(A) Year name type (uncertainty) (uncertainty) (approx.) Glue-on (*)nasal 50.9 42.9 1981 ResCare nasal 31.5 23.5 1993 standard (*) ResMednasal 29.5 21.5 1998 Mirage ™ (*) ResMed nasal 36 (3) 28 (3) 2000UltraMirage ™ ResMed Mirage nasal 32 (3) 24 (3) 2002 Activa ™ ResMedMirage nasal 30 (3) 22 (3) 2008 Micro ™ ResMed Mirage ™ nasal 29 (3) 22(3) 2008 SoftGel ResMed Mirage ™ nasal 26 (3) 18 (3) 2010 FX ResMedMirage nasal 37   29   2004 Swift ™ (*) pillows ResMed Mirage nasal 28(3) 20 (3) 2005 Swift ™ II pillows ResMed Mirage nasal 25 (3) 17 (3)2008 Swift ™ LT pillows ResMed AirFit nasal 21 (3) 13 (3) 2014 P10pillows (*) one specimen only, measured using test method specified inISO 3744 in CPAP mode at 10 cm H₂O)

Sound pressure values of a variety of objects are listed below

A-weighted sound pressure Object dB(A) Notes Vacuum cleaner: Nilfisk 68ISO 3744 at Walter Broadly Litter 1 m distance Hog: B+ GradeConversational speech 60 1 m distance Average home 50 Quiet library 40Quiet bedroom at night 30 Background in TV studio 20

2.2.4 Screening, Diagnosis, and Monitoring Systems

Polysomnography (PSG) is a conventional system for diagnosis andmonitoring of cardio-pulmonary disorders, and typically involves expertclinical staff to apply the system. PSG typically involves the placementof 15 to 20 contact sensors on a patient in order to record variousbodily signals such as electroencephalography (EEG), electrocardiography(ECG), electrooculograpy (EOG), electromyography (EMG), etc. PSG forsleep disordered breathing has involved two nights of observation of apatient in a clinic, one night of pure diagnosis and a second night oftitration of treatment parameters by a clinician. PSG is thereforeexpensive and inconvenient. In particular it is unsuitable for homescreening/diagnosis/monitoring of sleep disordered breathing.

Screening and diagnosis generally describe the identification of acondition from its signs and symptoms. Screening typically gives atrue/false result indicating whether or not a patient's SDB is severeenough to warrant further investigation, while diagnosis may result inclinically actionable information. Screening and diagnosis tend to beone-off processes, whereas monitoring the progress of a condition cancontinue indefinitely. Some screening/diagnosis systems are suitableonly for screening/diagnosis, whereas some may also be used formonitoring.

Clinical experts may be able to screen, diagnose, or monitor patientsadequately based on visual observation of PSG signals. However, thereare circumstances where a clinical expert may not be available, or aclinical expert may not be affordable. Different clinical experts maydisagree on a patient's condition. In addition, a given clinical expertmay apply a different standard at different times.

3 BRIEF SUMMARY OF THE TECHNOLOGY

The present technology is directed towards providing medical devicesused in the screening, diagnosis, monitoring, amelioration, treatment,or prevention of respiratory disorders having one or more of improvedcomfort, cost, efficacy, ease of use and manufacturability.

A first aspect of the present technology relates to apparatus used inthe screening, diagnosis, monitoring, amelioration, treatment orprevention of a respiratory disorder.

Another aspect of the present technology relates to methods used in thescreening, diagnosis, monitoring, amelioration, treatment or preventionof a respiratory disorder.

An aspect of certain forms of the present technology is to providemethods and/or apparatus that improve the compliance of patients withrespiratory therapy.

Another aspect of the present technology is directed to a patientinterface that may comprise: a plenum chamber; a seal-forming structure;and a positioning and stabilising structure. The patient interface mayfurther comprise a vent structure. The patient interface may further beconfigured to leave the patient's mouth uncovered, or if theseal-forming structure is configured to seal around the patient's noseand mouth, the patient interface may be further configured to allow thepatient to breath from ambient in the absence of a flow of pressurisedair through the plenum chamber inlet port.

Another aspect of the present technology is directed to a patientinterface comprising: a plenum chamber pressurisable to a therapeuticpressure of at least 4 cmH2O above ambient air pressure, said plenumchamber including a plenum chamber inlet port sized and structured toreceive a flow of air at the therapeutic pressure for breathing by apatient; a seal-forming structure constructed and arranged to seal witha region of the patient's face surrounding an entrance to the patient'sairways, said seal-forming structure having a hole therein such that theflow of air at said therapeutic pressure is delivered to at least anentrance to the patient's nares, the seal-forming structure constructedand arranged to maintain said therapeutic pressure in the plenum chamberthroughout the patient's respiratory cycle in use; a positioning andstabilising structure configured to hold the seal-forming structure in atherapeutically effective position on the patient's head, thepositioning and stabilising structure comprising a tie, the tie beingconstructed and arranged so that at least a portion overlies a region ofthe patient's head superior to an otobasion superior of the patient'shead in use; and a vent structure configured to allow a continuous flowof gases exhaled by the patient from an interior of the plenum chamberto ambient, said vent structure being sized and shaped to maintain thetherapeutic pressure in the plenum chamber in use; wherein the patientinterface is configured to leave the patient's mouth uncovered, or ifthe seal-forming structure is configured to seal around the patient'snose and mouth, the patient interface is configured to allow the patientto breath from ambient in the absence of a flow of pressurised airthrough the plenum chamber inlet port.

An aspect of the present technology relates to a patient interfaceincluding a frame assembly and a cushion assembly configured toremovably and repeatably connect to the frame assembly. The cushionassembly comprises a one-piece construction including a seal-formingstructure constructed and arranged to form a seal with a region of apatient's face surrounding the entrance to the patient's airways and aframe connection structure constructed and arranged to removably andrepeatably connect the cushion assembly to the frame assembly. Theseal-forming structure comprises a first elastomeric material and theframe connection structure comprise a second elastomeric material,wherein the first elastomeric material comprises a lower durometer orhardness than the second elastomeric material.

In an example, each of the first elastomeric material and the secondelastomeric material may comprise a TPE or silicone material.

An aspect of the present technology relates to a patient interface todeliver a flow of air at a positive pressure with respect to ambient airpressure to an entrance to the patient's airways including at least theentrance of a patient's nares while the patient is sleeping, toameliorate sleep disordered breathing. The patient interface includes aframe assembly and a cushion assembly configured to removably andrepeatably connect to the frame assembly. The frame assembly and thecushion assembly form at least part of a plenum chamber pressurizable toa therapeutic pressure. The cushion assembly comprises a one-piececonstruction including a seal-forming structure constructed and arrangedto form a seal with a region of a patient's face surrounding theentrance to the patient's airways and a frame connection structureconstructed and arranged to removably and repeatably connect the cushionassembly to the frame assembly. The seal-forming structure comprises afirst elastomeric material and the frame connection structure comprise asecond elastomeric material, wherein the first elastomeric materialcomprises a lower durometer or hardness than the second elastomericmaterial. The frame connection structure comprises an undercut that actsas an interface or catch adapted to connect to the frame assembly. Theframe connection structure is arranged along an interior surface orinterior periphery of the seal-forming structure such that the frameconnection structure and the undercut thereof is arranged or orientedtowards an interior of the cushion assembly that forms at least aportion of the plenum chamber.

In an example, the seal-forming structure may comprise a nasal cradlecushion adapted to from a seal against at least an underside of thepatient's nose. In an example, the seal-forming structure and the frameconnection structure may comprise an overmolded construction to form aone-piece integrated component. In an example, the frame connectionstructure may comprise a base mold and the seal-forming structure maycomprise an overmold provided to the base mold. In an example, each ofthe first elastomeric material and the second elastomeric material maycomprise a TPE or silicone material. In an example, the frame connectionstructure may comprise one or more interfacing surfaces structured tobond with the seal-forming structure. In an example, the firstelastomeric material may comprise a durometer in the range of 30-50Shore A and the second elastomeric material may comprise a durometer inthe range of 60-90 Shore A. In an example, the patient interface mayfurther comprise a sealing lip provided to the seal-forming structure ofthe first elastomeric material, the sealing lip constructed and arrangedto form a seal with the frame assembly. In an example, the frameassembly may be relatively harder than the frame connection structure.In an example, the frame connection structure and the undercut thereofmay extend around the entire perimeter or interior periphery of theseal-forming structure.

Another aspect of the present technology relates to a patient interfaceincluding a positioning and stabilising structure to provide a force tohold a seal-forming structure in a therapeutically effective position ona patient's head. The positioning and stabilizing structure includes afirst strap comprising an elastic material, a second strap comprising anelastic material, and a buckle constructed and arranged to connect thefirst strap to the second strap and permit length adjustment in additionto length adjustment provided by the elasticity of the first and secondstraps.

Another aspect of the present technology relates to a patient interfaceto deliver a flow of air at a positive pressure with respect to ambientair pressure to an entrance to the patient's airways including at leastthe entrance of a patient's nares while the patient is sleeping, toameliorate sleep disordered breathing. The patient interface includes aseal-forming structure constructed and arranged to form a seal with aregion of a patient's face surrounding the entrance to the patient'sairways and a positioning and stabilising structure to provide a forceto hold the seal-forming structure in a therapeutically effectiveposition on a patient's head. The positioning and stabilizing structureincludes a first strap comprising an elastic, textile material, a secondstrap comprising an elastic, textile material, and a buckle constructedand arranged to connect the first strap to the second strap and permitlength adjustment in addition to length adjustment provided by theelasticity of the first and second straps. The first strap includes aside strap portion that bifurcates into two back strap portions. Thesecond strap includes a side strap portion. The side strap portion ofthe second strap includes an end that is non-adjustably connected to thebuckle, and the two back strap portions of the first strap are threadedthrough the buckle to adjustably connect the first strap to the buckleand permit the length adjustment. The buckle includes a first openingand a pair of second openings, and the buckle includes a cross-bar thatdelineates the first opening from the pair of second openings. The twoback strap portions of the first strap are threaded through the firstopening, around the cross-bar, and through respective ones of the pairof second openings to adjustably connect the two back strap portions ofthe first strap to the buckle. The side strap portions of respectivefirst and second straps are adapted to extend along the sides of thepatient's head and the two back strap portions of the first strap areadapted to extend along the back of the patient's head.

In an example, the first strap may be longer than the second strap inits original length in a neutral, non-stretched state. In an example,one of the two back strap portions may be adapted to be positionedsuperior to the patient's occipital lobe and the other of the two backstrap portions may be adapted to be positioned inferior to the patient'soccipital lobe. In an example, the buckle may include a first endportion and a second end portion, the second end portion being connectedto the end of the side strap portion of the second strap, and the firstend portion may be curved or angled upwardly relative to the second endportion. In an example, each of the pair of second openings may includean angled edge or surface arranged to resist adjustment in use. In anexample, the buckle may comprise a locked position when the buckleextends generally parallel to the two back strap portions to resistunintentional adjustment due to friction between the two back strapportions and the angled edge or surface in respective second openings,and the buckle may comprise an unlocked position when lifted or pivotedso that the buckle extends transverse to the two back strap portions toallow adjustment due to reduced friction between the two back strapportions and the angled edge or surface in respective second openings.In an example, the positioning and stabilizing structure may furthercomprise a pair of rigidizer arms, and the side strap portions of thefirst and second straps are provided to respective ones of the pair ofrigidizer arms. In an example, each side strap portion may include atube-like configuration adapted to receive a respective one of therigidizer arms. In an example, each end of the first strap may include areinforcement portion, and the second strap may include an opposite end,opposite to the end connected to the buckle, that includes areinforcement portion, each reinforcement portion comprising a differentmaterial than the first and second straps.

An aspect of the present technology relates to a patient interfaceincluding a vent structured and arranged to improve diffusivity in airflow so as to minimize noise in use.

An aspect of the present technology relates to a patient interfaceincluding a vent with flow dividers to divide vent flow.

An aspect of the present technology relates to a patient interfaceincluding a vent with diffusing member(s) to diffuse vent flow and flowdividers to divide vent flow into spaced and separated vent flow pathsaround a perimeter of the patient interface.

An aspect of the present technology relates to a patient interface todeliver a flow of air at a positive pressure with respect to ambient airpressure to an entrance to the patient's airways including at least theentrance of a patient's nares while the patient is sleeping, toameliorate sleep disordered breathing. The patient interface includes aseal-forming structure constructed and arranged to form a seal with aregion of a patient's face surrounding the entrance to the patient'sairways, the seal-forming structure forming at least a portion of aplenum chamber pressurizable to a therapeutic pressure and a ventassembly configured to provide a vent flow of gas to discharge gasexhaled by the patient from the plenum chamber to ambient. The ventassembly includes a main body including a plurality of orificesextending through the main body to allow gas to be discharged from theplenum chamber to ambient, a diffusing member configured and arrangedsuch that the plurality of orifices are covered by the diffusing memberso that the vent flow of gas passes through the diffusing member, and aplurality of ribs. The plurality of ribs are configured and arranged tosupport the diffusing member in spaced relation from an outlet end ofeach of the plurality of orifices and divide the vent flow of gas intospaced and separated vent flow paths downstream from the diffusingmember around a perimeter of the main body.

In an example, the diffusing member may comprise a filter material. Inan example, the plurality of orifices may be arranged in an arc orU-shape. In an example, the plurality of ribs may be arranged along anouter periphery of the plurality of orifices to support an outer edge ofthe diffusing member. In an example, the vent assembly may furthercomprise a spacer provided to the main body, the spacer arranged alongan inner periphery of the plurality of orifices to support the diffusingmember. In an example, the patient interface may further comprise acover to retain the diffusing member to the main body. In an example,the main body and the cover may form a diffusion section including adiffusion section inlet and a diffusion section outlet, and theplurality of ribs are disposed within the diffusion section between thediffusion section inlet and the diffusion section outlet to divide thevent flow of gas. In an example, the diffusion section inlet of thediffusion section may be provided by an outlet end of each of theplurality of orifices. In an example, the plurality of ribs and thediffusing member may be provided within a recessed region of the mainbody, and the diffusion section outlet of the diffusion section may beprovided by a gap formed between the cover and a periphery of therecessed region. In an example, the diffusion section outlet may bespaced radially outwardly of the diffusion section inlet. In an example,the plurality of ribs may be constructed and arranged to divideturbulent kinetic energy at the diffusion section inlet into segmentstowards the diffusion section outlet. In an example, the plurality ofribs may be constructed and arranged to divide the turbulent kineticenergy into substantially equal segments. In an example, one or more ofthe plurality of ribs may be provided to the cover. In an example, oneor more of the plurality of ribs may comprise a one-piece constructionwith the cover. In an example, each of the plurality of ribs may extendin a generally orthogonal direction to a major face of the main body. Inan example, the plurality of orifices may comprise a first multi-holevent arrangement, and the vent assembly may further comprise a secondmulti-hole vent arrangement spaced apart from the first multi-hole ventarrangement, the second multi-hole vent arrangement including pluralityof orifices extending through the main body. In an example, the ventassembly may further comprise a second diffusing member configured andarranged to cover the plurality of orifices of the second multi-holevent arrangement, and the plurality of ribs may comprise ribs configuredand arranged to support the second diffusing member. In an example, thepatient interface may further comprise a frame assembly, and theseal-forming structure is provided to the frame assembly. In an example,the main body of the vent assembly may be provided by the frameassembly. In an example, the frame assembly may comprise a connectionport adapted to connect to an air delivery conduit. In an example, theplurality of orifices may be configured and arranged to prevent crossflow. In an example, one or more of the plurality of ribs may beprovided to the main body. In an example, one or more of the pluralityof ribs may comprise a one-piece construction with the main body.

An aspect of the present technology relates to a patient interface todeliver a flow of air at a positive pressure with respect to ambient airpressure to an entrance to the patient's airways including at least theentrance of a patient's nares while the patient is sleeping, toameliorate sleep disordered breathing. The patient interface includes aseal-forming structure constructed and arranged to form a seal with aregion of a patient's face surrounding the entrance to the patient'sairways, the seal-forming structure forming at least a portion of aplenum chamber pressurizable to a therapeutic pressure and a ventconfigured to provide a vent flow of gas to discharge gas exhaled by thepatient from the plenum chamber to ambient. The vent comprises a mainbody including a plurality of orifices extending through the main bodyto allow gas to be discharged from the plenum chamber to ambient. Themain body includes at least one ridge or rib providing a surface area,and an outlet end of each of the plurality of orifices is arranged alongthe surface area.

In an example, the main body may include a plurality of ridges or ribsproviding spaced-apart surface areas, and the outlet end of each of theplurality of orifices may be arranged along a respective one of thespaced-apart surface areas. In an example, the plurality of ridges orribs may be arranged to provide a stepped arrangement of surface areas.In an example, the spaced-apart surface areas may be generally parallelto one another. In an example, the plurality of orifices may be arrangedin columns, and each of the columns may be arranged along a respectiveone of the spaced-apart surface areas. In an example, the plurality oforifices may comprise a first multi-hole vent arrangement, and the ventmay further comprise a second multi-hole vent arrangement spaced apartfrom the first multi-hole vent arrangement, the second multi-hole ventarrangement may include plurality of orifices extending through the mainbody. In an example, the patient interface may further comprise a frameassembly, and the seal-forming structure may be provided to the frameassembly. In an example, the main body of the vent may be provided bythe frame assembly.

An aspect of the present technology relates to a CPAP system forproviding gas at positive pressure for respiratory therapy to a patient,the CPAP system including an RPT device configured to supply a flow ofgas at a therapeutic pressure, a patient interface, and an air deliveryconduit configured to pass a flow of gas at therapeutic pressure fromthe RPT device to the patient interface.

Another aspect of one form of the present technology is a patientinterface that is moulded or otherwise constructed with a perimetershape which is complementary to that of an intended wearer.

An aspect of one form of the present technology is a method ofmanufacturing apparatus.

An aspect of certain forms of the present technology is a medical devicethat is easy to use, e.g. by a person who does not have medicaltraining, by a person who has limited dexterity, vision or by a personwith limited experience in using this type of medical device.

An aspect of one form of the present technology is a patient interfacethat may be washed in a home of a patient, e.g., in soapy water, withoutrequiring specialised cleaning equipment.

Of course, portions of the aspects may form sub-aspects of the presenttechnology. Also, various ones of the sub-aspects and/or aspects may becombined in various manners and also constitute additional aspects orsub-aspects of the present technology.

Other features of the technology will be apparent from consideration ofthe information contained in the following detailed description,abstract, drawings and claims.

4 BRIEF DESCRIPTION OF THE DRAWINGS

The present technology is illustrated by way of example, and not by wayof limitation, in the figures of the accompanying drawings, in whichlike reference numerals refer to similar elements including:

4.1 Treatment Systems

FIG. 1A shows a system including a patient 1000 wearing a patientinterface 3000, in the form of nasal pillows, receiving a supply of airat positive pressure from an RPT device 4000. Air from the RPT device4000 is humidified in a humidifier 5000, and passes along an air circuit4170 to the patient 1000. A bed partner 1100 is also shown. The patientis sleeping in a supine sleeping position.

FIG. 1B shows a system including a patient 1000 wearing a patientinterface 3000, in the form of a nasal mask, receiving a supply of airat positive pressure from an RPT device 4000. Air from the RPT device ishumidified in a humidifier 5000, and passes along an air circuit 4170 tothe patient 1000.

FIG. 1C shows a system including a patient 1000 wearing a patientinterface 3000, in the form of a full-face mask, receiving a supply ofair at positive pressure from an RPT device 4000. Air from the RPTdevice is humidified in a humidifier 5000, and passes along an aircircuit 4170 to the patient 1000. The patient is sleeping in a sidesleeping position.

4.2 Respiratory System and Facial Anatomy

FIG. 2A shows an overview of a human respiratory system including thenasal and oral cavities, the larynx, vocal folds, oesophagus, trachea,bronchus, lung, alveolar sacs, heart and diaphragm.

FIG. 2B shows a view of a human upper airway including the nasal cavity,nasal bone, lateral nasal cartilage, greater alar cartilage, nostril,lip superior, lip inferior, larynx, hard palate, soft palate,oropharynx, tongue, epiglottis, vocal folds, oesophagus and trachea.

FIG. 2C is a front view of a face with several features of surfaceanatomy identified including the lip superior, upper vermilion, lowervermilion, lip inferior, mouth width, endocanthion, a nasal ala,nasolabial sulcus and cheilion. Also indicated are the directionssuperior, inferior, radially inward and radially outward.

FIG. 2D is a side view of a head with several features of surfaceanatomy identified including glabella, sellion, pronasale, subnasale,lip superior, lip inferior, supramenton, nasal ridge, alar crest point,otobasion superior and otobasion inferior. Also indicated are thedirections superior & inferior, and anterior & posterior.

FIG. 2E is a further side view of a head. The approximate locations ofthe Frankfort horizontal and nasolabial angle are indicated. The coronalplane is also indicated.

FIG. 2F shows a base view of a nose with several features identifiedincluding naso-labial sulcus, lip inferior, upper Vermilion, naris,subnasale, columella, pronasale, the major axis of a naris and themidsagittal plane.

FIG. 2G shows a side view of the superficial features of a nose.

FIG. 2H shows subcutaneal structures of the nose, including lateralcartilage, septum cartilage, greater alar cartilage, lesser alarcartilage, sesamoid cartilage, nasal bone, epidermis, adipose tissue,frontal process of the maxilla and fibrofatty tissue.

FIG. 2I shows a medial dissection of a nose, approximately severalmillimeters from the midsagittal plane, amongst other things showing theseptum cartilage and medial crus of greater alar cartilage.

FIG. 2J shows a front view of the bones of a skull including thefrontal, nasal and zygomatic bones. Nasal concha are indicated, as arethe maxilla, and mandible.

FIG. 2K shows a lateral view of a skull with the outline of the surfaceof a head, as well as several muscles. The following bones are shown:frontal, sphenoid, nasal, zygomatic, maxilla, mandible, parietal,temporal and occipital. The mental protuberance is indicated. Thefollowing muscles are shown: digastricus, masseter, sternocleidomastoidand trapezius.

FIG. 2L shows an anterolateral view of a nose.

4.3 Patient Interface

FIG. 3A shows a patient interface in the form of a nasal mask inaccordance with one form of the present technology.

FIG. 3B shows a schematic of a cross-section through a structure at apoint. An outward normal at the point is indicated. The curvature at thepoint has a positive sign, and a relatively large magnitude whencompared to the magnitude of the curvature shown in FIG. 3C.

FIG. 3C shows a schematic of a cross-section through a structure at apoint. An outward normal at the point is indicated. The curvature at thepoint has a positive sign, and a relatively small magnitude whencompared to the magnitude of the curvature shown in FIG. 3B.

FIG. 3D shows a schematic of a cross-section through a structure at apoint. An outward normal at the point is indicated. The curvature at thepoint has a value of zero.

FIG. 3E shows a schematic of a cross-section through a structure at apoint. An outward normal at the point is indicated. The curvature at thepoint has a negative sign, and a relatively small magnitude whencompared to the magnitude of the curvature shown in FIG. 3F.

FIG. 3F shows a schematic of a cross-section through a structure at apoint. An outward normal at the point is indicated. The curvature at thepoint has a negative sign, and a relatively large magnitude whencompared to the magnitude of the curvature shown in FIG. 3E.

FIG. 3G shows a cushion for a mask that includes two pillows. Anexterior surface of the cushion is indicated. An edge of the surface isindicated. Dome and saddle regions are indicated.

FIG. 3H shows a cushion for a mask. An exterior surface of the cushionis indicated. An edge of the surface is indicated. A path on the surfacebetween points A and B is indicated. A straight line distance between Aand B is indicated. Two saddle regions and a dome region are indicated.

FIG. 3I shows the surface of a structure, with a one dimensional hole inthe surface. The illustrated plane curve forms the boundary of a onedimensional hole.

FIG. 3J shows a cross-section through the structure of FIG. 3I. Theillustrated surface bounds a two dimensional hole in the structure ofFIG. 3I.

FIG. 3K shows a perspective view of the structure of FIG. 31 , includingthe two dimensional hole and the one dimensional hole. Also shown is thesurface that bounds a two dimensional hole in the structure of FIG. 3I.

FIG. 3L shows a mask having an inflatable bladder as a cushion.

FIG. 3M shows a cross-section through the mask of FIG. 3L, and shows theinterior surface of the bladder. The interior surface bounds the twodimensional hole in the mask.

FIG. 3N shows a further cross-section through the mask of FIG. 3L. Theinterior surface is also indicated.

FIG. 3O illustrates a left-hand rule.

FIG. 3P illustrates a right-hand rule.

FIG. 3Q shows a left ear, including the left ear helix.

FIG. 3R shows a right ear, including the right ear helix.

FIG. 3S shows a right-hand helix.

FIG. 3T shows a view of a mask, including the sign of the torsion of thespace curve defined by the edge of the sealing membrane in differentregions of the mask.

FIG. 3U shows a view of a plenum chamber 3200 showing a sagittal planeand a mid-contact plane.

FIG. 3V shows a view of a posterior of the plenum chamber of FIG. 3U.The direction of the view is normal to the mid-contact plane. Thesagittal plane in FIG. 3V bisects the plenum chamber into left-hand andright-hand sides.

FIG. 3W shows a cross-section through the plenum chamber of FIG. 3V, thecross-section being taken at the sagittal plane shown in FIG. 3V. A‘mid-contact’ plane is shown. The mid-contact plane is perpendicular tothe sagittal plane. The orientation of the mid-contact plane correspondsto the orientation of a chord 3210 which lies on the sagittal plane andjust touches the cushion of the plenum chamber at two points on thesagittal plane: a superior point 3220 and an inferior point 3230.Depending on the geometry of the cushion in this region, the mid-contactplane may be a tangent at both the superior and inferior points.

FIG. 3X shows the plenum chamber 3200 of FIG. 3U in position for use ona face. The sagittal plane of the plenum chamber 3200 generallycoincides with the midsagittal plane of the face when the plenum chamberis in position for use. The mid-contact plane corresponds generally tothe ‘plane of the face’ when the plenum chamber is in position for use.In FIG. 3X the plenum chamber 3200 is that of a nasal mask, and thesuperior point 3220 sits approximately on the sellion, while theinferior point 3230 sits on the lip superior.

4.4 Patient Interface According to the Present Technology

FIG. 4 is a perspective view of a patient interface shown on a patient'shead according to an example of the present technology.

FIG. 5 is a perspective view of the patient interface of FIG. 4according to an example of the present technology.

FIG. 6 is a side view of the patient interface shown in FIG. 5 .

FIG. 7 is a perspective view of the patient interface of FIG. 5according to an example of the present technology, the patient interfacebeing shown with a headgear strap assembly removed.

FIG. 8 is a front view of the patient interface shown in FIG. 7 .

FIG. 9 is a cross-sectional view through line 9-9 of FIG. 8 .

FIG. 10 is a cross-sectional view through line 10-10 of FIG. 8 .

FIG. 11 is an enlarged portion of the cross-section shown in FIG. 10 .

FIG. 12 is a cross-sectional view through line 12-12 of FIG. 8 .

FIG. 13 is an enlarged portion of the cross-section shown in FIG. 12 .

FIG. 14 is a front view of the patient interface shown in FIG. 7 showingvent flow paths of a vent according to an example of the presenttechnology.

FIG. 15 is an exploded view when viewed from the front of the patientinterface shown in FIG. 7 .

FIG. 16 is another exploded view when viewed from the front of thepatient interface shown in FIG. 7 .

FIG. 17 is an exploded view when viewed from the rear of the patientinterface shown in FIG. 7 .

FIG. 18 is an exploded view when viewed from the bottom of the patientinterface shown in FIG. 7 .

FIG. 19 is a perspective view of a main body of a frame assembly of thepatient interface shown in FIG. 7 .

FIG. 20 is a top view of the main body of the frame assembly shown inFIG. 19 .

FIG. 21 is a front view of the main body of the frame assembly shown inFIG. 19 .

FIG. 22 is an enlarged portion of the main body of the frame assemblyshown in FIG. 21 .

FIG. 23 is a perspective view of a cover of a frame assembly of thepatient interface shown in FIG. 7 .

FIG. 24 is a top view of the cover of the frame assembly shown in FIG.23 .

FIG. 25 is a perspective view of a cushion assembly of the patientinterface shown in FIG. 7 .

FIG. 26 is another perspective view of the cushion assembly shown inFIG. 25 .

FIG. 27 is another perspective view of the cushion assembly shown inFIG. 25 .

FIG. 28 is a top view of the cushion assembly shown in FIG. 25 .

FIG. 29 is a cross-sectional view through line 29-29 of FIG. 28 .

FIG. 30 is an enlarged portion of the cross-section shown in FIG. 29 .

FIG. 31 is a perspective view of a cushion assembly of the patientinterface shown in FIG. 7 .

FIG. 32 is a front view of the cushion assembly shown in FIG. 31 .

FIG. 33 is a perspective view of a cushion assembly of the patientinterface shown in FIG. 7 .

FIG. 34 is another perspective view of the cushion assembly shown inFIG. 33 .

FIG. 35 is a rear view of the cushion assembly shown in FIG. 33 .

FIG. 36 is a side view of the cushion assembly shown in FIG. 33 .

FIG. 37 is a bottom view of the cushion assembly shown in FIG. 33 .

FIG. 38 is a top view of a cushion assembly for a patient interfaceaccording to an example of the present technology.

FIG. 39 is a side view of the cushion assembly of FIG. 38 .

FIG. 40 is a top view of a cushion assembly for a patient interfaceaccording to an example of the present technology.

FIG. 41 is a side view of the cushion assembly of FIG. 40 .

FIG. 42 is a top view of a cushion assembly for a patient interfaceaccording to an example of the present technology.

FIG. 43 is a side view of the cushion assembly of FIG. 42 .

FIG. 44A is a schematic perspective view showing a headgear strapassembly of the patient interface of FIG. 4 according to an example ofthe present technology.

FIG. 44B shows a cross-section through line 44B-44B of FIG. 44A.

FIG. 45 is a top view of headgear strap assembly of the patientinterface of FIG. 4 according to an example of the present technology.

FIG. 46 is an exploded view of the headgear strap assembly of FIG. 45 .

FIG. 47 is an enlarged view of an end of a strap portion of the headgearstrap assembly of FIG. 45 .

FIG. 48 is a perspective view of a buckle of the headgear strap assemblyof FIG. 45 .

FIG. 49 is a front view of the buckle of FIG. 48 .

FIG. 50 is a top view of the buckle of FIG. 48 .

FIG. 51 is a cross-sectional view of the buckle of FIG. 48 .

FIG. 52 is an enlarged portion of the cross-section shown in FIG. 51 .

FIGS. 53 and 54 are cross-sectional views showing strap adjustment ofthe headgear strap assembly according to an example of the presenttechnology.

FIG. 55 is a side view of a patient interface shown on a patient's headaccording to an example of the present technology, the patient interfacebeing shown with the headgear strap assembly in a first adjustedposition.

FIG. 56 is a side view of a patient interface shown on a patient's headaccording to an example of the present technology, the patient interfacebeing shown with the headgear strap assembly in a second adjustedposition.

FIG. 57 is a perspective view showing a cover of a frame assembly of thepatient interface according to an example of the present technology.

FIG. 58 is a perspective view showing a main body of a frame assembly ofthe patient interface according to an example of the present technology.

FIG. 59 is a perspective view of a cushion assembly for a patientinterface according to an example of the present technology.

FIG. 60 is a perspective view showing a main body of a frame assembly ofthe patient interface according to an example of the present technology.

FIG. 61 is a cross-sectional view showing alignment features of thecushion assembly and the main body of the frame assembly of the patientinterface according to an example of the present technology.

FIG. 62 is a top view of a cushion assembly for a patient interfaceaccording to an example of the present technology.

FIG. 63 is a bottom view of the cushion assembly of FIG. 62 .

FIG. 64 is a perspective view of the cushion assembly of FIG. 62 .

FIG. 65 is another perspective view of the cushion assembly of FIG. 62 .

FIG. 66 is a cross-sectional view of the cushion assembly of FIG. 62 .

FIG. 67 is another cross-sectional view of the cushion assembly of FIG.62 .

FIG. 68 is a top view of a cushion assembly for a patient interfaceaccording to an example of the present technology.

FIG. 69 is a bottom view of the cushion assembly of FIG. 68 .

FIG. 70 is a perspective view of the cushion assembly of FIG. 68 .

FIG. 71 is another perspective view of the cushion assembly of FIG. 68 .

FIG. 72 is a perspective view of a cushion assembly for a patientinterface according to an example of the present technology.

FIG. 73 is a front view of the cushion assembly shown in FIG. 72 .

FIG. 74 is a perspective view of the cushion assembly shown in FIG. 72connected to the main body of a frame assembly according to an exampleof the present technology.

FIG. 75 is an exploded view of the cushion assembly and the main body ofthe frame assembly shown in FIG. 74 .

FIG. 76 is a perspective view of a patient interface according toanother example of the present technology, the patient interface beingshown with a headgear strap assembly removed.

FIG. 77 is an exploded view when viewed from the front of the patientinterface shown in FIG. 76 .

FIG. 78 is an exploded view when viewed from the rear of the patientinterface shown in FIG. 76 .

FIG. 79 is a perspective view showing the frame assembly of the patientinterface shown in FIG. 76 according to an example of the presenttechnology.

FIG. 80 is a front view of the frame assembly shown in FIG. 79 .

FIG. 81 is a top view of the frame assembly shown in FIG. 79 .

FIG. 82A is an enlarged portion of the frame assembly shown in FIG. 79 .

FIG. 82B is a cross-sectional view of the frame assembly shown in FIG.82A.

FIG. 82C is a cross-sectional view of the patient interface shown inFIG. 79 .

FIG. 83A to 83D are various views showing fitting of the patientinterface according to an example of the present technology.

FIGS. 84A and 84B are various views showing adjusting of the headgearstrap assembly of the patient interface according to an example of thepresent technology.

FIG. 85 is a view showing removing of the patient interface according toan example of the present technology.

FIGS. 86A and 86B are various views showing adjusting of the buckle ofthe patient interface according to an example of the present technology.

5 DETAILED DESCRIPTION OF EXAMPLES OF THE TECHNOLOGY

Before the present technology is described in further detail, it is tobe understood that the technology is not limited to the particularexamples described herein, which may vary. It is also to be understoodthat the terminology used in this disclosure is for the purpose ofdescribing only the particular examples discussed herein, and is notintended to be limiting.

The following description is provided in relation to various exampleswhich may share one or more common characteristics and/or features. Itis to be understood that one or more features of any one example may becombinable with one or more features of another example or otherexamples. In addition, any single feature or combination of features inany of the examples may constitute a further example.

5.1 Therapy

In one form, the present technology comprises a method for treating arespiratory disorder comprising the step of applying positive pressureto the entrance of the airways of a patient 1000.

In certain examples of the present technology, a supply of air atpositive pressure is provided to the nasal passages of the patient viaone or both nares.

In certain examples of the present technology, mouth breathing islimited, restricted or prevented.

5.2 Treatment Systems

In one form, the present technology comprises an apparatus or device fortreating a respiratory disorder. The apparatus or device may comprise anRPT device 4000 for supplying pressurised air to the patient 1000 via anair circuit 4170 to a patient interface 3000, e.g., see FIGS. 1A to 1C.

5.3 Patient Interface

Referring to FIGS. 4 to 18 , a non-invasive patient interface 3000 inaccordance with one aspect of the present technology comprises a frameassembly 3500, a cushion assembly 3075 including a seal-formingstructure 3100 and a frame connection structure 3150, and a positioningand stabilizing structure 3300. In some forms, a functional aspect maybe provided by one or more physical components. In some forms, onephysical component may provide one or more functional aspects. In usethe seal-forming structure 3100 is arranged to surround an entrance tothe airways of the patient so as to facilitate the supply of air atpositive pressure to the airways.

In the illustrated example, the frame assembly 3500 includes a vent 3400and a connection port 3600 for connection to a short tube 4180 of theair circuit 4170. The frame assembly 3500 also functions as a centralhub to which the cushion assembly 3075, the positioning and stabilizingstructure 3300, and the short tube 4180 are connected, e.g., either in aremovable fashion or a more permanent fashion. The frame assembly 3500is structured to allow sealing forces to be transferred to the cushionassembly 3075 from the positioning and stabilizing structure 3300.

In one form of the present technology, the frame assembly 3500 and thecushion assembly 3075 are repeatedly and removably engageable with oneanother, e.g., to allow cleaning and/or replacement of the cushionassembly 3075. The frame assembly 3500 and the cushion assembly 3075form a plenum chamber 3200 when the frame assembly 3500 and the cushionassembly 3075 are engaged. The plenum chamber 3200 may receive a flow ofpressurised gas from the short tube 4180 of the air circuit 4170, whichmay pass through the seal-forming structure 3100 and into the patient'sairways for inhalation.

If a patient interface is unable to comfortably deliver a minimum levelof positive pressure to the airways, the patient interface may beunsuitable for respiratory pressure therapy.

The patient interface 3000 in accordance with one form of the presenttechnology is constructed and arranged to be able to provide a supply ofair at a positive pressure of at least 6 cmH₂O with respect to ambient.

The patient interface 3000 in accordance with one form of the presenttechnology is constructed and arranged to be able to provide a supply ofair at a positive pressure of at least 10 cmH₂O with respect to ambient.

The patient interface 3000 in accordance with one form of the presenttechnology is constructed and arranged to be able to provide a supply ofair at a positive pressure of at least 20 cmH₂O with respect to ambient.

5.3.1 Seal-Forming Structure

In one form of the present technology, a seal-forming structure 3100provides a target seal-forming region, and may additionally provide acushioning function. The target seal-forming region is a region on theseal-forming structure 3100 where sealing may occur. The region wheresealing actually occurs—the actual sealing surface—may change within agiven treatment session, from day to day, and from patient to patient,depending on a range of factors including for example, where the patientinterface was placed on the face, tension in the positioning andstabilising structure and the shape of a patient's face.

In one form the target seal-forming region is located on an outsidesurface of the seal-forming structure 3100.

In certain forms of the present technology, the seal-forming structure3100 is constructed from a biocompatible material, e.g. silicone rubber.

A seal-forming structure 3100 in accordance with the present technologymay be constructed from a soft, flexible, resilient material such assilicone.

In certain forms of the present technology, a system is providedcomprising more than one a seal-forming structure 3100, each beingconfigured to correspond to a different size and/or shape range. Forexample the system may comprise one form of a seal-forming structure3100 suitable for a large sized head, but not a small sized head andanother suitable for a small sized head, but not a large sized head.

5.3.1.1 Sealing Mechanisms

In one form, the seal-forming structure includes a sealing flangeutilizing a pressure assisted sealing mechanism. In use, the sealingflange can readily respond to a system positive pressure in the interiorof the plenum chamber 3200 acting on its underside to urge it into tightsealing engagement with the face. The pressure assisted mechanism mayact in conjunction with elastic tension in the positioning andstabilising structure.

In one form, the seal-forming structure 3100 comprises a sealing flangeand a support flange. The sealing flange comprises a relatively thinmember with a thickness of less than about 1 mm, for example about 0.25mm to about 0.45 mm, which extends around the perimeter of the plenumchamber 3200. Support flange may be relatively thicker than the sealingflange. The support flange is disposed between the sealing flange andthe marginal edge of the plenum chamber 3200, and extends at least partof the way around the perimeter. The support flange is or includes aspring-like element and functions to support the sealing flange frombuckling in use.

In one form, the seal-forming structure may comprise a compressionsealing portion or a gasket sealing portion. In use the compressionsealing portion, or the gasket sealing portion is constructed andarranged to be in compression, e.g. as a result of elastic tension inthe positioning and stabilising structure.

In one form, the seal-forming structure comprises a tension portion. Inuse, the tension portion is held in tension, e.g. by adjacent regions ofthe sealing flange.

In one form, the seal-forming structure comprises a region having atacky or adhesive surface.

In certain forms of the present technology, a seal-forming structure maycomprise one or more of a pressure-assisted sealing flange, acompression sealing portion, a gasket sealing portion, a tensionportion, and a portion having a tacky or adhesive surface.

5.3.1.2 Nose Bridge or Nose Ridge Region

In one form, the non-invasive patient interface 3000 comprises aseal-forming structure that forms a seal in use on a nose bridge regionor on a nose-ridge region of the patient's face.

In one form, the seal-forming structure includes a saddle-shaped regionconstructed to form a seal in use on a nose bridge region or on anose-ridge region of the patient's face.

5.3.1.3 Upper Lip Region

In one form, the non-invasive patient interface 3000 comprises aseal-forming structure that forms a seal in use on an upper lip region(that is, the lip superior) of the patient's face.

In one form, the seal-forming structure includes a saddle-shaped regionconstructed to form a seal in use on an upper lip region of thepatient's face.

5.3.1.4 Chin-Region

In one form the non-invasive patient interface 3000 comprises aseal-forming structure that forms a seal in use on a chin-region of thepatient's face.

In one form, the seal-forming structure includes a saddle-shaped regionconstructed to form a seal in use on a chin-region of the patient'sface.

5.3.1.5 Forehead Region

In one form, the seal-forming structure that forms a seal in use on aforehead region of the patient's face. In such a form, the plenumchamber may cover the eyes in use.

5.3.1.6 Nasal Pillows

In one form the seal-forming structure of the non-invasive patientinterface 3000 comprises a pair of nasal puffs, or nasal pillows, eachnasal puff or nasal pillow being constructed and arranged to form a sealwith a respective naris of the nose of a patient.

Nasal pillows in accordance with an aspect of the present technologyinclude: a frusto-cone, at least a portion of which forms a seal on anunderside of the patient's nose, a stalk, a flexible region on theunderside of the frusto-cone and connecting the frusto-cone to thestalk. In addition, the structure to which the nasal pillow of thepresent technology is connected includes a flexible region adjacent thebase of the stalk. The flexible regions can act in concert to facilitatea universal joint structure that is accommodating of relative movementboth displacement and angular of the frusto-cone and the structure towhich the nasal pillow is connected. For example, the frusto-cone may beaxially displaced towards the structure to which the stalk is connected.

5.3.1.7 Nasal Cradle

FIGS. 25 to 37 show the seal-forming structure 3100 of the according toan example of the present technology. In the illustrated example, theseal-forming structure 3100 may be considered a nasal cradle cushion andintended to provide a flow of pressurised gas to the patient's nares bysealing against at least the underside of the patient's nose, e.g., seeFIGS. 4, 55, and 56 . The exemplary seal-forming structures 3100 willengage the patient's face below the bridge of the nose and someexamples, depending on the size and shape of the patient's nose, mayengage the patient's nose below the pronasale. The exemplaryseal-forming structures 3100 will also engage the patient's face atleast above the upper vermillion Thus, the exemplary seal-formingstructures 3100 may seal against the patient's lip superior in use.Furthermore, the patient's mouth may remain uncovered by theseal-forming structure 3100 of the depicted examples such that thepatient may breathe freely, i.e., directly to atmosphere, withoutinterference from the seal-forming structure 3100.

The exemplary nasal cradle cushion may include a superior saddle orconcave region that has positive curvature across the cushion. Also, thenasal cradle cushion may be understood to have a single target sealforming region or surface, in contrast to a pillows cushion may have twotarget seal forming regions (one for each naris). Cradle cushions mayalso have a posterior wall that contacts the patient's lip superior andan upper, central, surface contacts the underside of the patient's nose.These two surfaces on the patient's face may form a nasolabial anglebetween them (see FIG. 2E). A cradle cushion may be shaped to have anasolabial angle within the range of 90 degrees to 120 degrees.

Furthermore, the exemplary seal-forming structure 3100 may also beshaped and dimensioned such that no portion of the seal-formingstructure 3100 enters into the patient's nares during use.

As best shown in FIGS. 33 to 37 , the exemplary seal-forming structure3100 may include at least two regions of different thickness: lateralsupport regions 3108 and a medial region 3114. In further examples,there may also be a third region (in addition to the lateral supportregions 3108 and the medial region 3114) of another different thickness,a mid-lateral region 3110. In still further examples, there may one ormore additional regions (in addition to the lateral support regions3108, the mid-lateral regions 3110, and the medial region 3114) ofdifferent thicknesses. As can be seen in the depicted example, thediffering thicknesses may be produced by extending regions of differentthickness different distances into the interior of the seal-formingstructure 3100 such that the exterior surface of the seal-formingstructure 3100 remains smooth. The exterior surface may not be uneven attransitional areas between the regions of different thickness. Thus, theexterior of the exemplary seal-forming structures 3100 is continuous andsmooth.

In the depicted example, naris openings 3102 may be formed through themedial region 3114. The naris openings 3102 are positioned to generallyalign with patient's corresponding naris to provide the flow ofpressurised gas to the patient's nares for inhalation and for exhaledgas to be passed back into the seal-forming structure 3100 for dischargeto atmosphere via the vent 3400. Within the medial region 3114, theremay also be a bridge portion 3104 positioned between the naris openings3102.

In an example, the seal-forming structure 3100 in different examples maybe sized and shaped differently and, accordingly, each variation mayprovide an optimal fit for patients having noses and faces shaped andsized differently.

In an example, the seal-forming structure 3100 may include two or moredifferent sizes/shapes. For example, FIGS. 38-39 show an exemplary smallsize seal-forming structure 3100, FIGS. 40-41 show an exemplarysmall-wide size seal-forming structure 3100, and FIGS. 42-43 show anexemplary medium size seal-forming structure 3100. As illustrated, sizedimensions and/or contours of the seal-forming structure may be variedto provide alternative seal forming surfaces for different patients.

In an example, one or more thickened portions (e.g., thickened portionof silicone) may be provided to one or more regions of the seal-formingstructure 3100 to add support and stability to the one or more regions,e.g., to ensure cushion stability and seal performance. In an example,the one or more thickened portions may be produced by increasing thethickness of the seal-forming structure 3100 in one or more regions intothe interior of the seal-forming structure 3100 such that the exteriorsurface of the seal-forming structure 3100 remains continuous andsmooth. The one or more thickened portions may include similar ordifferent thicknesses relative to one another. In an example, thethickness of thickened portion(s) and/or the specific positioning of thethickened portion(s) along the seal-forming structure 3100 may be atleast partially dependent on the size of the seal-forming structure3100.

For example, FIGS. 62 to 67 show an exemplary small-wide sizeseal-forming structure 3100 including a thickened portion 3120 along atop side of the seal-forming structure 3100 (closer to the nose bridge)and a thickened portion 3121 along a bottom side of the seal-formingstructure 3100 (closer to the upper lip), e.g., thickened portions 3120,3121 provided along lower sides of the seal-forming structure 3100 closeto the frame connection structure 3150 in a medial region 3114 of theseal-forming structure 3100.

In contrast, FIGS. 68 to 71 show an exemplary medium size seal-formingstructure 3100 including thickened portions 3122 along a bottom side ofthe seal-forming structure 3100 (closer to the upper lip), e.g.,thickened portions 3122 provided along lower sides of the seal-formingstructure 3100 close to the frame connection structure 3150 inrespective lateral support regions 3108 of the seal-forming structure3100. In this example, no additional thickened portions are provided tothe medium size seal-forming structure 3100 along a top side of theseal-forming structure 3100 (closer to the nose bridge).

However, it should be appreciated that other examples, e.g., thicknessand/or positioning, of thickened portions in one or more regions of theseal-forming structure 3100 are possible.

5.3.2 Frame Connection Structure

As shown in FIGS. 25 to 30 , the frame connection structure 3150 isstructured and arranged to removably and repeatedly connect the cushionassembly 3075 to the frame assembly 3500, e.g., to facilitate cleaning,replacement, and/or to change for a different cushion assembly 3075having a differently sized seal-forming structure 3100 as describedabove in relation to FIGS. 38-43 .

The frame connection structure 3150 includes a seal connecting portion3160 adapted to connect to the seal-forming structure 3100 and a frameconnecting portion 3170 adapted to connect to the frame assembly 3500.

The frame connection structure 3150 may be permanently (e.g.,overmolded) or removably (e.g., interference fit assembly) connected tothe seal-forming structure 3100.

Overmolded Construction

In the illustrated example, the frame connection structure 3150 and theseal-forming structure 3100 comprise an overmolded construction to forma one-piece, integrated component.

For example, the frame connection structure 3150 comprises a first partor base mold and the seal-forming structure 3100 comprises a second partor overmold that is provided (e.g., by overmolding) to the first part.

In an example, the frame connection structure 3150 comprises a materialthat is more rigid than the seal-forming structure 3100. In an example,the frame connection structure 3150 and the seal-forming structure 3100may comprise a similar material (e.g., thermoplastic elastomer (TPE) orsilicone), with the frame connection structure 3150 having a higherdurometer (e.g., higher Shore A hardness) than the seal-formingstructure 3100, thereby providing a dual-durometer component.

In an example, the cushion assembly 3075 may be formed by a 2-shotsequential overmolding process in which different materials are injectedin the same molding machine to form the cushion assembly 3075. Forexample, in the first step, the molding machine injects a first materialinto a closed cavity (i.e., first shot) to form the frame connectionstructure 3150 (i.e., the first part or base mold) into its shape. Inthe second step, the molding machine injects a second material into theremaining space of the closed cavity (i.e., second shot) to form theseal-forming structure 3100 (i.e., the second part or overmold) into itsshape as an overmold onto the frame connection structure 3150. In anexample, the frame connection structure 3150 may comprise an insertafter the first shot, and the molding machine may move the mold coresand/or the insert (i.e., frame connection structure 3150) to create asecond cavity for forming the seal-forming structure 3100 in the secondshot.

In an example, the seal-forming structure 3100 may be overmolded to theframe connection structure 3150 from a material that is able tochemically bond or self-adhere to the material of the frame connectionstructure 3150. For example, as shown in FIG. 30 , the seal connectingportion 3160 of the frame connection structure 3150 may provide one ormore interfacing surfaces 3615 (e.g., land area) structured to bond withthe seal-forming structure 3100. Such bond may be made stronger byincreasing the land area. In an example, the seal connecting portion3160 may provide a chemical bond without a mechanical interlock. As aresult, the connection includes no cracks, a gas tight seal, and cleaninterface.

As a result, the entire cushion assembly 3075 may comprise siliconematerial with areas of different hardness. In an example, the frameconnection structure 3150 (i.e., the first shot or base mold) maycomprise a higher durometer silicone material (e.g., Shore A hardnessgreater than 60 Shore A, e.g., 65 Shore A, 60-70 Shore A, 60-90 shore A,up to 70 Shore A, up to 90 Shore A), and the seal-forming structure 3100(i.e., the second shot or overmold) may comprise a lower durometersilicone material than the frame connection structure 3150 (e.g., ShoreA hardness greater than 30 Shore A, e.g., 40 Shore A, 30-50 Shore A,less than 50 Shore A).

In an example, the frame connection structure 3150 (i.e., the first shotor base mold) may comprise a higher durometer LSR material, and theseal-forming structure 3100 (i.e., the second shot or overmold) maycomprise a lower durometer LSR material. However, it should beappreciated that other suitable materials may be used.

The higher durometer, frame connection structure 3150 comprises a morerigid material adapted for connection to the frame assembly 3500. Asillustrated, the frame connecting portion 3170 of the frame connectionstructure 3150 forms a barbed end or undercut 3175 that acts as aninterface or catch adapted to connect to the frame assembly 3500. Theuse of silicone material and the overmolding process for forming theframe connection structure 3150 allows for demolding of the barbed endor undercut, which allows the cushion assembly to comprise a smallersize and profile (e.g., smaller and easier to fabricate than overmoldingseal onto a hard plastic clip). The use of higher durometer, siliconematerial for the frame connection structure 3150 also has the advantagesof being more robust against physical damage by external forces (e.g.,crush-resistant unlike a hard plastic clip) and having less expensivemanufacturing costs.

In the illustrated example, the frame connection structure 3150 isarranged along an interior surface or interior periphery of theseal-forming structure 3100 such that the frame connection structure3150 is arranged or oriented towards the interior of the cushionassembly, i.e., the frame connection structure 3150 projects inwardlyfrom the interior surface or interior periphery of the seal-formingstructure 3100 towards the cavity of the seal-forming structure 3100,which forms at least a portion of the plenum chamber 3200. Thisarrangement allows the frame connection structure 3150 and undercut 3175thereof to be stretched over and onto the frame assembly 3500 forattachment.

In an example, the frame connection structure 3150 and undercut 3175thereof extends around the entire perimeter or the entire interiorperiphery of the seal-forming structure 3100. In an alternative example,the frame connection structure 3150 and undercut 3175 thereof may extendalong one or more selected portions of the perimeter of the seal-formingstructure 3100, e.g., along a partial interior periphery of theseal-forming structure 3100.

In an example, the frame connection structure 3150 may provide a profilethat forms a smooth and continuous curve along the periphery of thecavity of the seal-forming structure 3100, e.g., frame connectionstructure 3150 flush with the seal-forming structure 3100. In anexample, the length of the frame connection structure 3150 protrudinginto the cavity may be the same along the entire perimeter of theseal-forming structure 3100. It should be appreciated that, inalternative examples, the profile of the frame connection structure 3150may vary along one or more portions of the periphery the seal-formingstructure 3100. For example, the length of the frame connectionstructure 3150 may vary along one or more portions of the perimeter ofthe seal-forming structure 3100.

The lower durometer, seal-forming structure 3100 comprises a softer,more comfortable material adapted for sealing with a patient's face. Inaddition, a sealing lip 3850 is formed along with the seal-formingstructure 3100 of the lower durometer material. As described below, thesealing lip 3850 is arranged along an interior surface or interiorperiphery of the seal-forming structure 3100 and adapted to form a sealwith the frame assembly 3500 (e.g., when pressure is increased withinthe plenum chamber 3200), e.g., to prevent leaks for more effectivetreatment and patient satisfaction.

In the illustrated example, the frame connection structure 3150 isprovided along the edge of the cavity of the seal-forming structure3100, and the sealing lip 3850 is arranged inward of the frameconnection structure 3150 within the cavity. The frame connectionstructure 3150 and the sealing lip 3850 form a space therebetween toreceive a portion of the frame assembly 3500 for attachment of thecushion assembly 3075 to the frame assembly 3500 as described below.

In an example, the frame connection structure 3150 (i.e., the first shotor base mold) may comprise a similar color or a different color than theseal-forming structure 3100 (i.e., the second shot or overmold), e.g.,both the frame connection structure 3150 and the seal-forming structure3100 comprise a clear or generally transparent color.

In an example, the frame connection structure 3150 (i.e., the first shotor base mold) may comprise a similar surface finish or a differentsurface finish than the seal-forming structure 3100 (i.e., the secondshot or overmold), e.g., the frame connection structure 3150 comprises ahighly polished surface finish and the seal-forming structure 3100comprises a textured surface finish.

FIGS. 31 and 32 are alternative views of the cushion assembly 3075showing a contrast between the frame connection structure 3150 and theseal-forming structure 3100 according to an example of the presenttechnology.

5.3.3 Frame Assembly

As best shown in FIGS. 15 to 24 , the frame assembly 3500 comprises amain body 3510 and a cover 3580 provided to an anterior side of the mainbody 3510.

In an example, the main body 3510 and the cover 3580 may be constructed(e.g., molded) of a relative rigid material, e.g., polypropylene,polycarbonate.

The main body 3510 includes a body portion 3520, a cushion connectingportion 3530, and a cover connecting portion 3540. Also, as described inmore detail below, the main body 3510 and the cover 3580 cooperate toform the vent 3400 and cooperate to maintain diffusing members 3450,e.g., filter materials, of the vent 3400 within the frame assembly 3500.

In the illustrated example, each of a pair of rigidizer arms 3302 of thepositioning and stabilising structure 3300 are connected to respectivesides of the main body 3510 by a respective one of a pair of flexiblejoints 3305. In an example, the flexible joints 3305 may be permanentlyconnected to the main body 3510 and may be permanently connected torespective rigidizer arms 3302, e.g., via overmold, interference fitassembly. However, the rigidizer arms 3302 may be connected to the mainbody 3510 in other suitable manners.

The cover 3580 includes an anterior wall 3585 and a tube portion 3590.The tube portion 3590 comprises the connection port 3600 for connectionto a short tube 4180 of the air circuit 4170. In an example, the cover3580 may also be referred to as a tube connector.

In the illustrated example, the short tube 4180 may be directlyconnected or otherwise provided to the connection port 3600 without theuse of an elbow or swivel elbow. For example, the short tube 4180 may bedirectly connected to an anterior side of the tube portion 3590 of thecover 3580. The short tube 4180 may be permanently or removablyconnected to the connection port 3600. Permanent connection may be byway of overmolding or interference fit assembly. In an alternativeexample, the short tube 4180 may be connected to the connection port3600 via an elbow or swivel elbow. In yet another example, the aircircuit 4170 may be connected (e.g., directly or via an elbow) to theconnection port 3600 without the use of a short tube 4180.

In the illustrated example, the anterior side of the anterior wall 3585includes contoured surfaces that blend into the anterior side of thetube portion 3590, e.g., for aesthetics as the anterior wall andanterior side of the tube portion 3590 provides a front side of thepatient interface 3000.

In the illustrated example, the posterior side of the tube portion 3590protrudes from a posterior side of the anterior wall 3585. The coverconnecting portion 3540 of the main body 3510 is in the form of a tubeadapted to receive the posterior side of the tube portion 3590, e.g., intelescoping manner, to align and connect the cover 3580 to the main body3510. As illustrated, the tube portion 3590 and the cover connectingportion 3540 includes a snap or interference fit assembly, e.g.,posterior side of the tube portion 3590 includes a peripheral groove3595 adapted to engage a peripheral bead 3545 along the interior of thecover connecting portion 3540 (e.g., see FIG. 13 ). However, it shouldbe appreciated that the cover 3580 may be connected to the main body3510 in other suitable manners, e.g., either in a removable fashion or amore permanent fashion.

In the illustrated example, the posterior side of the anterior wall 3585provides a stop to prevent over-insertion of the tube portion 3590 intothe cover connecting portion 3540 of the main body 3510. Also, in anexample, the recessed region 3550 in the anterior side of the main body3510 includes a plurality of ribs 3560 along its perimeter that form aportion of the vent 3400, and such ribs 3560 may provide a step 3562structured and arranged to provide a stop for the outer edge of theanterior wall 3585. Such stops maintain spacing between the anteriorwall 3585 and the sides and bottom of the recessed region 3550, whichforms a diffusion section for the vent 3400 including diffusing members3450, as discussed in more detail below.

In an example, the cover 3580 and the main body 3510 may each include analignment feature to ensure that the cover 3580 and the main body 3510are correctly aligned or oriented for assembly. For example, as bestshown in FIGS. 57 and 58 , the cover 3580 may include a protrusion 3581(e.g., male alignment feature) adapted to receive a corresponding recess3511 (e.g., female alignment feature) in the main body 3510. However,other suitable alignment features are possible.

In an example, the frame assembly 3500 (e.g., see main body 3510 andanterior wall of the cover 3580) includes a curvature (e.g. when viewedfrom the top as shown in FIGS. 20 and 24 ) intended to follow thenatural curvature of patient's upper lip and may avoid concentration ofcontact pressure on any specific point of the patient's upper lip suchthat contact pressure from headgear tension is evenly spread over thepatient's upper lip, e.g., to minimise or eliminate skin breakdowncaused by prolonged concentrated contact pressure. Another advantage forthe curvature is that less material may be required, which leads to anoverall weight reduction for the patient interface 3000. The curvaturealso minimizes any protrusion of the patient interface 3000 in theanterior direction from the patient's face which improves theunobtrusiveness of the patient interface 3000.

In an example, the frame assembly 3500 may be made in one size but thecushion assembly 3075 may be made in multiple sizes that are attachableto the single frame assembly 3500 by commonly sized connectionsfeatures, e.g., cushion sizes include different sized seal-formingstructures with common sized frame connection structures for attachmentto the common frame assembly 3500.

5.3.4 Connection Between Cushion Assembly and Frame Assembly

In the illustrated example, the frame connecting portion 3170 of thecushion assembly 3075 and the cushion connecting portion 3530 of theframe assembly 3500 includes an interference fit assembly.

For example, the frame connecting portion 3170 of the cushion assembly3075 forms the barbed end or undercut 3175, and the cushion connectingportion 3530 of the frame assembly 3500 includes a channel with anundercut 3535 along a posterior wall of the channel. As shown in FIG. 13, the barbed end or undercut 3175 of the frame connecting portion 3170is structured and arranged to engage over and behind the undercut 3535of the cushion connecting portion 3530 to releasably connect the cushionassembly 3075 to the frame assembly 3500. In an example, the barbed endof the frame connecting portion 3170 and the channel of the frameassembly 3500 forms a tongue and groove arrangement to removably andrepeatedly connect the cushion assembly 3075 to the frame assembly 3500.

In an example, the relatively flexible material of the cushion assembly3075 allows the frame connection structure 3150 and the frame connectingportion 3170 thereof to be stretched over the cushion connecting portion3530 until the barbed end or undercut 3175 of the frame connectingportion 3170 can catch or interface with the undercut 3535 of thecushion connecting portion 3530, e.g., frame connection structure 3150forms a relatively flexible ring that can be stretched over therelatively harder frame assembly 3500 for attachment.

As shown in FIG. 30 , the frame connecting portion 3170 of the frameconnection structure 3150 may include a tapered or angled leadingsurface 3171 to guide and facilitate outward deflection of the frameconnecting portion 3170 over and behind the cushion connecting portion3530 of the frame assembly 3500, e.g., tapered or angled leading surface3171 adapted to engage a tapered or angled leading surface on cushionconnecting portion 3530 of the frame assembly 3500 to facilitateassembly.

In an example, the higher durometer, frame connection structure 3150 maybe or act as a “cushion clip” structured and arranged to removably andrepeatedly clip the cushion assembly 3075 to the frame assembly 3500.For example, the increased hardness provided by the higher durometermaterial of the frame connection structure 3150 may act as clipstructure structured to reduce deformation of the frame connectionstructure 3150, thereby allowing the frame connection structure 3150 tomaintain engagement between the cushion assembly 3075 and the frameassembly 3500 and resist removal of the cushion assembly 3075 from theframe assembly 3500.

The cushion assembly 3075 and the frame assembly 3500 may bedisconnected by applying enough force for the frame connection structure3150 of the cushion assembly 3075 to be stretched out of the channel toescape or clear the undercut 3535 of the cushion connecting portion 3530of the frame assembly 3500.

Sealing Lip

As noted above, a sealing lip 3850 is formed along with the seal-formingstructure 3100 of the lower durometer material. As best shown in FIGS.29-30 , the sealing lip 3850 is in the form of a flexible flap arrangedalong an interior surface or interior periphery of the seal-formingstructure 3100. The sealing lip 3850 protrudes into a cavity of theseal-forming structure 3100, which forms at least a portion of theplenum chamber 3200.

In an example, as shown in FIG. 13 , the sealing lip 3850 is structuredand arranged to engage the frame assembly 3500 to form a pneumatic sealwith the cushion connecting portion 3530 of the frame assembly 3500(e.g., posterior wall of the channel). In an example, the sealing lip3850 may be structured and arranged to engage the frame assembly 3500when the cushion assembly 3075 is initially connected to the frameassembly 3500, e.g., sealing lip 3850 arranged to deflect against thecushion connecting portion 3530 of the frame assembly 3500 byinterference. When pressure within the plenum chamber 3200 is increasedabove atmospheric pressure for treating breathing disorders, thepneumatic seal is strengthened and increases the sealing force as thesealing lip 3850 is urged with greater force against the frame assembly3500.

In an alternative example, the sealing lip 3850 may be spaced from oradjacent to the frame assembly 3500 when the cushion assembly 3075 isinitially connected to the frame assembly 3500, and the sealing lip 3850forms the seal with the frame assembly 3500 when pressure is increasedwithin the plenum chamber 3200.

The sealing lip 3850 is sufficiently long so that the sealing lip 3850does not get caught or trapped in the frame assembly 3500 when the frameconnection structure 3150 of the cushion assembly 3075 is stretched overthe cushion connecting portion 3530 of the frame assembly 3500 duringassembly.

In an example, the length of the sealing lip 3850 may be the same alongthe entire perimeter of the seal-forming structure 3100. In alternativeexamples, the length of the sealing lip 3850 may vary along one or moreportions of the perimeter of the seal-forming structure 3100.

For example, as shown in the example of FIGS. 72 and 73 , the sealinglip 3850 may be longer at the two lateral ends or sides of theseal-forming structure 3100 to prevent the sealing lip 3850 from beingcaught or trapped when the cushion assembly 3075 is stretched andreleased laterally during its assembly onto the frame assembly 3500.This configuration is best shown in FIG. 73 which shows the portions ofthe sealing lip 3850 at the two lateral ends or sides of theseal-forming structure 3100 being longer (i.e., protruding further intothe cavity of the seal-forming structure 3100) than the portions of thesealing lip 3850 at the top (superior) and bottom (inferior) sides ofthe seal-forming structure 3100.

Further, the curvature of the sealing lip 3850 may vary along one ormore portions of the perimeter of the seal-forming structure 3100. Forexample, as best shown in FIG. 72 , the longer, sealing lip 3850 at thetwo lateral ends or sides of the seal-forming structure 3100 may alsoinclude a curvature so that the sealing lip 3850 at the two lateral endsor sides of the seal-forming structure 3100 protrudes or curves furtheraway from the frame connection structure 3150 than the portions of thesealing lip 3850 at the top (superior) and bottom (inferior) sides ofthe seal-forming structure 3100. Such arrangement may also facilitateassembly of the cushion assembly 3075 onto the lateral ends of the frameassembly 3500 without the sealing lip 3850 being caught or trapped,e.g., sufficient space provided between the frame connection structure3150 and the sealing lip 3850 to allow connection of the frameconnection structure 3150 without the sealing lip 3850 getting trappedin the frame assembly 3500 during assembly.

Alignment Features

In an example, the patient interface 3000 may include visual indicatorsand/or tactile indicators to prevent or minimise misorientation andimproper assembly/disassembly. This may ensure properassembly/disassembly, avoid inadvertent damage to the patient interface3000, and also ease any user frustration associated withassembly/disassembly.

In an example, the cushion assembly 3075 and the frame assembly 3500 mayeach include an alignment feature to ensure that the cushion assembly3075 and the frame assembly 3500 are correctly aligned or oriented forassembly.

For example, as best shown in FIGS. 16 to 18 , the cushion connectingportion 3530 of the frame assembly 3500 may include one or moreprotrusions 3537 (e.g., male alignment feature) within the channeladapted to receive a corresponding one of one or more recesses 3177(e.g., female alignment feature) along the frame connecting portion 3170of the cushion assembly 3075. As illustrated, the protrusions3537/recesses 3177 are only provided on one side of the frame assembly3500/cushion assembly 3500 (e.g., superior side) to ensure properorientation of the cushion assembly 3075 when connected to the frameassembly 3500.

In an alternative example, as shown in FIGS. 59-61 , the cushionconnecting portion 3530 of the frame assembly 3500 may include a singleprotrusion 3537 on a lateral side of the frame assembly 3500 that isadapted to receive a corresponding recess 3177 along a lateral side ofthe frame connecting portion 3170 of the cushion assembly 3075.

In another example, as shown in FIGS. 72-75 , the cushion connectingportion 3530 of the frame assembly 3500 may include a single protrusion3577 on a central, superior side of the frame assembly 3500 that isadapted to receive a corresponding cut-out 3179 along a central,superior side of the cushion assembly 3075.

In the example of FIGS. 16-18 and 59-61 , the recess(s) 3177 areprovided on the inner side of the periphery of the frame connectionstructure 3150. In the example of FIGS. 72-75 , the cut-out 3179comprises a complete cut-through on the periphery of the frameconnection structure 3150 so that a distinct recess is provided on theedge of the cushion assembly 3075. In contrast to the example of FIGS.16-18 and 59-61 , the cut-out configuration of FIGS. 72-75 and itslocation on a central, superior side of the cushion assembly 3075 mayprovide a clearer, visual indication to the patient to allow them tomore easily assemble the cushion assembly 3075 to the frame assembly3500 in the correct orientation.

In should be appreciated that the alignment feature may includealternative shapes and locations. For example, the alignment feature maybe provided along any portion or portions along the periphery of thecushion assembly and frame assembly, and the alignment feature mayinclude any suitable shape, e.g., cut-out or recess on inner or outerside of the frame connection structure 3150. Further, it should beappreciated that any suitable number of alignment features may beprovided (e.g., any suitable number of cut-outs and/or recesses), andalignment feature alternatives may be combinable with one another, e.g.,see FIG. 75 including frame assembly 3500 with both protrusion 3577 andprotrusions 3537 adapted to receive a cut-out 3179 and recesses 3177(not shown) on the inner side of the frame connection structure 3150. Ineach example, the alignment feature is arranged such that misalignmentand incorrect assembly of the cushion assembly 3075 to the frameassembly 3500 may be reduced. In an example, the alignment feature mayprevent assembly unless the alignment feature of the cushion assembly3075 and the frame assembly 3500 are aligned with one another.

5.3.5 Plenum Chamber

The plenum chamber 3200 has a perimeter that is shaped to becomplementary to the surface contour of the face of an average person inthe region where a seal will form in use. In use, a marginal edge of theplenum chamber 3200 is positioned in close proximity to an adjacentsurface of the face. Actual contact with the face is provided by theseal-forming structure 3100. The seal-forming structure 3100 may extendin use about the entire perimeter of the plenum chamber 3200. In someforms, the plenum chamber 3200 and the seal-forming structure 3100 areformed from a single homogeneous piece of material.

In certain forms of the present technology, the plenum chamber 3200 doesnot cover the eyes of the patient in use. In other words, the eyes areoutside the pressurised volume defined by the plenum chamber. Such formstend to be less obtrusive and/or more comfortable for the wearer, whichcan improve compliance with therapy.

In certain forms of the present technology, the plenum chamber 3200 isconstructed from a transparent material, e.g. a transparentpolycarbonate. The use of a transparent material can reduce theobtrusiveness of the patient interface, and help improve compliance withtherapy. The use of a transparent material can aid a clinician toobserve how the patient interface is located and functioning.

In certain forms of the present technology, the plenum chamber 3200 isconstructed from a translucent material. The use of a translucentmaterial can reduce the obtrusiveness of the patient interface, and helpimprove compliance with therapy.

5.3.6 Positioning and Stabilising Structure

The seal-forming structure 3100 of the patient interface 3000 of thepresent technology may be held in sealing position in use by thepositioning and stabilising structure 3300.

In one form the positioning and stabilising structure 3300 provides aretention force at least sufficient to overcome the effect of thepositive pressure in the plenum chamber 3200 to lift off the face.

In one form the positioning and stabilising structure 3300 provides aretention force to overcome the effect of the gravitational force on thepatient interface 3000.

In one form the positioning and stabilising structure 3300 provides aretention force as a safety margin to overcome the potential effect ofdisrupting forces on the patient interface 3000, such as from tube drag,or accidental interference with the patient interface.

In one form of the present technology, a positioning and stabilisingstructure 3300 is provided that is configured in a manner consistentwith being worn by a patient while sleeping. In one example thepositioning and stabilising structure 3300 has a low profile, orcross-sectional thickness, to reduce the perceived or actual bulk of theapparatus. In one example, the positioning and stabilising structure3300 comprises at least one strap having a rectangular cross-section. Inone example the positioning and stabilising structure 3300 comprises atleast one flat strap.

In one form of the present technology, a positioning and stabilisingstructure 3300 is provided that is configured so as not to be too largeand bulky to prevent the patient from lying in a supine sleepingposition with a back region of the patient's head on a pillow.

In one form of the present technology, a positioning and stabilisingstructure 3300 is provided that is configured so as not to be too largeand bulky to prevent the patient from lying in a side sleeping positionwith a side region of the patient's head on a pillow.

In one form of the present technology, a positioning and stabilisingstructure 3300 is provided with a decoupling portion located between ananterior portion of the positioning and stabilising structure 3300, anda posterior portion of the positioning and stabilising structure 3300.The decoupling portion does not resist compression and may be, e.g. aflexible or floppy strap. The decoupling portion is constructed andarranged so that when the patient lies with their head on a pillow, thepresence of the decoupling portion prevents a force on the posteriorportion from being transmitted along the positioning and stabilisingstructure 3300 and disrupting the seal.

In one form of the present technology, a positioning and stabilisingstructure 3300 comprises a strap constructed from a laminate of a fabricpatient-contacting layer, a foam inner layer and a fabric outer layer.In one form, the foam is porous to allow moisture, (e.g., sweat), topass through the strap. In one form, the fabric outer layer comprisesloop material to engage with a hook material portion.

In certain forms of the present technology, a positioning andstabilising structure 3300 comprises a strap that is extensible, e.g.resiliently extensible. For example the strap may be configured in useto be in tension, and to direct a force to draw a seal-forming structureinto sealing contact with a portion of a patient's face. In an examplethe strap may be configured as a tie.

In one form of the present technology, the positioning and stabilisingstructure comprises a first tie, the first tie being constructed andarranged so that in use at least a portion of an inferior edge thereofpasses superior to an otobasion superior of the patient's head andoverlays a portion of a parietal bone without overlaying the occipitalbone.

In one form of the present technology suitable for a nasal-only mask orfor a full-face mask, the positioning and stabilising structure includesa second tie, the second tie being constructed and arranged so that inuse at least a portion of a superior edge thereof passes inferior to anotobasion inferior of the patient's head and overlays or lies inferiorto the occipital bone of the patient's head.

In one form of the present technology suitable for a nasal-only mask orfor a full-face mask, the positioning and stabilising structure includesa third tie that is constructed and arranged to interconnect the firsttie and the second tie to reduce a tendency of the first tie and thesecond tie to move apart from one another.

In certain forms of the present technology, a positioning andstabilising structure 3300 comprises a strap that is bendable and e.g.non-rigid. An advantage of this aspect is that the strap is morecomfortable for a patient to lie upon while the patient is sleeping.

In certain forms of the present technology, a positioning andstabilising structure 3300 comprises a strap constructed to bebreathable to allow moisture vapour to be transmitted through the strap,

In certain forms of the present technology, a system is providedcomprising more than one positioning and stabilizing structure 3300,each being configured to provide a retaining force to correspond to adifferent size and/or shape range. For example the system may compriseone form of positioning and stabilizing structure 3300 suitable for alarge sized head, but not a small sized head, and another. suitable fora small sized head, but not a large sized head.

Referring to FIGS. 4-7 and 44-56 , a positioning and stabilisingstructure 3300 is shown according to an example of the presenttechnology. In the illustrated example, the positioning and stabilisingstructure 3300 comprises a pair of rigidizer arms 3302 and a headgearstrap assembly 3330 provided to the pair of rigidizer arms 3302. Therigidizer arms 3302 and the headgear strap assembly 3330 cooperate tohold the patient interface 3000 of the present technology in sealingposition in use, e.g., rigidizer arms 3302 direct tension vectorsgenerated by the headgear strap assembly 3330 so that the seal-formingstructure 3100 seals against the base of the patient's nose.

As noted above, each of a pair of rigidizer arms 3302 is connected torespective sides of the main body 3510 of the frame assembly 3500 by arespective one of a pair of flexible joints 3305. However, the rigidizerarms 3302 may be connected to the main body 3510 in other suitablemanners.

In the illustrated example, the headgear strap assembly 3330 includes apair of straps 3340, 3350 (e.g., each constructed of an elastic textile)which are connected to one another by an adjustment mechanism, e.g., abuckle 3360, which permits length adjustment, e.g., in addition to thelength adjustment provided by the elasticity of the straps 3340, 3350 asdescribed below.

As illustrated, the pair of straps comprises a first, longer strap 3340and a second, shorter strap 3350, the first strap 3340 being longer thanthe second strap 3350 in its original length in a neutral, non-stretchedstate.

Each strap 3340, 3350 may be made of an elastic material and may haveelastic properties. In other words, each strap may be elasticallystretched to increase the length of the strap, e.g., by a stretchingforce applied by the patient, and upon release of the stretching force,returns or contracts to its original length in a neutral state. Eachstrap may be made of or comprise any elastomeric material such aselastane, TPE, silicone etc. The material of each strap may alsorepresent a combination of any of the above materials with othermaterials. Each strap may be a single layer or multilayer strap. Eachstrap may be woven, knitted, braided, molded, extruded or otherwiseformed. Each strap may comprise or may be made of a textile materialsuch as a woven material. Such material may comprise artificial ornatural fibers for, on the one hand, providing desired and beneficialsurface properties such as tactile properties and skin comfort. On theother hand, the material of each strap may include elastomeric materialfor providing the desired elastomeric properties. In the illustratedexample, each strap is stretchable. This enables the entire length ofeach strap to be stretched which leads to a comfortable forcedisplacement profile.

The first strap 3340 includes a side strap portion 3342 and a back strapportion 3344. As illustrated, the back strap portion 3344 includes asplit region that splits the back strap portion 3344 into two back strapportions 3344 a, 3344 b, i.e., the side strap portion 3342 bifurcatesinto two back strap portions 3344 a, 3344 b. The second strap 3350includes a side strap portion 3352.

In the illustrated example, one end of the side strap portion 3352 isnon-adjustably connected to the buckle 3360, and the two back strapportions 3344 a, 3344 b of back strap portion 3344 are wound or threadedthrough the buckle 3360 to permit adjustment relative to the buckle3360.

The headgear strap assembly 3330 is rigidised at a certain section, forexample, from the frame assembly 3500 up to a position proximal to thepatient's cheekbone by the inserted rigidiser arms 3302. Each strap3340, 3350 of the headgear strap assembly 3330 may take the form of ahollow ribbon structured to receive a respective one of the rigidiserarms 3302 therein. Each strap may be considered to be threaded over arespective one of the rigidiser arms 3302 when it is slipped onto therespective rigidiser arm 3302 and secured at one end of the respectiverigidiser arm 3302 proximal to the frame assembly 3500.

In the illustrated example, each strap 3340, 3350 has a tube-likeconfiguration as can be taken from the schematic view in FIG. 44Aindicating an oval or circular shape, as well as by the exemplarycross-sectional view according to FIG. 44B. However, it will beappreciated that the positioning and stabilising structure 3300 may takeany other shape such as flat or sheet-like shape, single, multi-layer orlaminate construction.

The side strap portions 3342, 3352 of respective straps 3340, 3350 eachinclude a button-hole 3343, 3353, e.g., slit-like configuration. Thebutton-holes 3343, 3353 may be located at the outer surface ofrespective straps 3340, 3350, i.e., the surface facing away from thepatient when being worn, and are adapted to receive a respectiverigidiser arm 3302 in order to insert the rigidiser arm 3302 into theinterior of the tube- or sleeve-like strap 3340, 3350 or to remove ittherefrom. Alternatively, the button-holes 3343, 3353 may be located atthe inner surface of respective straps 3340, 3350. In an example, eachside strap portion 3342, 3352 may include a pocketed end adapted toreceive an end of the respective rigidiser arm 3302 proximal to theframe assembly 3500.

In the illustrated, each end of the first strap 3340 includes areinforcement portion or finger tab 3345, 3347, and the end of thesecond strap 3350 opposite to the buckle 3360 includes a reinforcementportion or finger tab 3355. In an example, each reinforcement portion orfinger tab 3345, 3347, 3355 comprises a different material than thestraps 3340, 3350, e.g., TPE material. In an example, each reinforcementportion or finger tab 3345, 3347, 3355 may be overmolded to respectiveends of the straps 3340, 3350, however each reinforcement portion orfinger tab 3345, 3347, 3355 may be connected to the straps in othersuitable manners.

Each reinforcement portion or finger tab 3345, 3347, 3355 providesreinforcement to respective ends of the straps 3340, 3350, e.g. to avoidor mitigate the likelihood of a patient tearing or ripping the straps3340, 3350. Further, the reinforcement portion or finger tabs 3345, 3355helps provide a visual and tactile indication to the patient on how toslip on or remove the straps 3340, 3350 from respective rigidiser arms3302 and may assist in identifying the location of the button-holes3343, 3353. Also, the reinforcement portion or finger tab 3347 isprovided (e.g., overmolded) to the end of the two back strap portions3344 a, 3344 b after the two back strap portions 3344 a, 3344 b arewound or threaded through the buckle 3360 in order to prevent removal ofthe strap 3340 from the buckle 3360. Further, the reinforcement portionor finger tab 3347 provides a visual and tactile indication foradjustment of the back strap portion 3344 relative to the buckle 3360.

As shown in FIGS. 4, 55, and 56 , the side strap portions 3342, 3352 ofrespective straps 3340, 3350 are adapted to extend along the sides of apatient's head when being worn while back strap portion 3344 of strap3340 is adapted to extend along the back of a patient's head.

In order for the headgear strap assembly 3330 to be stretched in use,the length of the headgear strap assembly 3330 may be less than theaverage small head circumference of patients. For example, the length ofthe headgear strap assembly 3330 (e.g., the length of the headgearassembly with the back strap portion 3340 fully retracted with respectto the buckle 3360 as shown in FIG. 45 ) may be less than 600 mm in oneexample and less than 500 mm in another example. However, headgear strapassembly 3330 of different lengths may be provided to patients dependingon their head circumference which may be gender specific.

In the illustrated example, the straps 3340, 3350 are joined by thebuckle 3360 which permits length adjustment in addition to the lengthadjustment provided by the elasticity of the straps 3340, 3350. Asillustrated, the buckle 3360 includes a main body 3362 with a first endportion 3364 and a second end portion 3366. In the illustrated example,the first end portion 3364 is curved or angled upwardly relative to thesecond end portion 3366. The second end portion 3366 is connected to anend of the strap 3350, e.g., via overmolding. The main body 3362includes openings for receiving back strap portions 3344 a, 3344 b,i.e., a first opening 3370 configured to receive both back strapportions 3344 a, 3344 b and a pair of second openings 3372 a, 3372 bconfigured to respective ones of the back strap portions 3344 a, 3344 b.A cross-bar 3380 delineates the first opening 3370 from the secondopenings 3372 a, 3372 b, and cross-bar 3382 delineates opening 3372 afrom opening 3372 b.

As illustrated, the back strap portions 3344 a, 3344 b are threaded upthrough the first opening 3370, around the cross-bar 3380, and downthrough respective ones of the second openings 3372 a, 3372 b. Each ofthe second openings 3372 a, 3372 b includes an angled edge or surface3375 arranged to resist adjustment in use.

In an example, the buckle 3360 comprises a relatively rigid material,e.g., polypropylene, polyethylene, and may include an overmold, e.g.,comprising TPE material. For example, in the exemplary cross-section ofthe buckle 3360 in FIGS. 51 and 52 , the buckle 3360 includes arelatively rigid base 3390, e.g., polypropylene, polyethylene, with asofter overmold 3391, e.g., TPE. In the illustrated example, theovermold 3391 is not provided along the openings 3370, 3372 a, 3372 b.In an example, one or portions may be polished, e.g., regionssurrounding the openings 3370, 3372 a, 3372 b as shown by the hatchedareas in FIG. 50 , e.g., to reduce friction and facilitate gliding orsliding adjustment of the back strap portions 3344 a, 3344 b relative tothe buckle 3360. However, other suitable material are possible.

FIGS. 53-56 are exemplary views showing strap adjustment of the headgearstrap assembly 3330 according to an example of the present technology.The headgear strap assembly 3330 allows for precise adjustment of thetensioning and therefore ensuring better sealing of the cushion assembly3075, especially after repeated use and/or washing of the headgear strapassembly 3330 which may lead to a loss of the strap elasticity. Adequatetensioning by the headgear strap assembly 3330 may be especiallyimportant for the nasal cradle type seal-forming structure 3100 of thepresent technology, e.g., compared to a pillows type seal-formingstructure where less tension is required for sealing.

The adjustment mechanism (e.g., a buckle 3360) is operable to allow the(effective) length of the elastic straps 3340, 3350 to be adjusted bythe patient to maintain the required stretch force and fit over time.For example, the elastic straps 3340, 3350 may be joined by the buckle3360 in a first adjusted position (e.g., with the back strap portion3340 substantially retracted with respect to the buckle 3360 as shown inFIGS. 45 and 55 ) and one or more second adjusted positions (e.g., withthe back strap portion 3340 overlapped to a different extent than thefirst adjusted positon as shown in FIG. 56 ). In each adjusted position,the headgear strap assembly 3330 may comprise (1) a neutral orunstretched state in which the headgear strap assembly 3330 comprises aneutral or unstretched length (i.e., no stretching force applied to theelastic straps 3340, 3350 to elastically stretch the straps 3340, 3350),and (2) one or more extended or stretched states in which the headgearstrap assembly 3330 comprises one or more extended or stretched lengths(i.e., stretching force applied to the elastic straps 3340, 3350 toelastically stretch and increase the length of the straps 3340, 3350).In each adjusted position, the material of the straps 3340, 3350 limitsthe extended or stretched length in the extended position to a certainextent, i.e., the maximum or effective length the headgear strapassembly 3330 in each adjusted position. When the elastic strap 3340 isadjusted relative to the buckle 3360 (e.g., from a first adjustedposition to a second adjusted position), the neutral or unstretchedlength of the headgear strap assembly 3330 changes, e.g., the lengthshortens when adjusted from a first adjusted position to a secondadjusted position. Such shortened length in the neutral or unstretchedstate also shortens the extended or stretched lengths, e.g., the maximumor effective length the headgear strap assembly 3330 in the secondadjusted position is shortened. This arrangement allows adjustment ofthe maximum or effective stretchable length, e.g., to accommodate lossof strap elasticity so as to maintain a comfortable force displacementprofile. Thus, the elasticity of the straps 3340, 3350 provides anadjustment mechanism to permit length adjustment in a given adjustedposition, and the buckle 3360 provides an additional adjustmentmechanism to permit length adjustment in addition to the extent oflength adjustment provide by the elasticity of the straps 3340, 3350.

As shown in FIG. 53 , the buckle 3360 is in a locked position when thebuckle extends generally parallel to the back strap portions 3344 a,3344 b to resist unintentional adjustment due to friction between theback strap portions 3344 a, 3344 b, respective free ends of the backstrap portions 3344 a, 3344 b, and the angled edge or surface 3375 inrespective second openings 3372 a, 3372 b. As shown in FIG. 54 , thebuckle 3360 can be lifted or pivoted to an unlocked position so that thebuckle extends transverse to the back strap portions 3344 a, 3344 b toallow adjustment due to reduced friction between the back strap portions3344 a, 3344 b, respective free ends of the back strap portions 3344 a,3344 b, and the angled edge or surface 3375 in respective secondopenings 3372 a, 3372 b. That is, the buckle 3360 in the unlockedposition may be angled to allow for the back strap portions 3344 a, 3344b to glide easily relative to the buckle 3360 for length adjustment.This arrangement is achieved by multiple forward and backwards bends ofthe back strap portions 3344 a, 3344 b wrapping around the cross-bar3380 within the buckle 3360, e.g., Capstan effect working principle.

Such arrangement provides a simple, easy-to-use, buckle adjustmentmechanism for the patient, especially when the patient interface isdonned by the patient. In an example, such adjustment arrangement may beperformed by one hand and may include one-step adjustment, e.g., simplypull the free end of the back strap portions 3344 a, 3344 b (e.g., viareinforcement portion or finger tab 3347) relative to the buckle 3360 totighten and simply pivot and pull the buckle 3360 relative to the backstrap portions 3344 a, 3344 b to loosen.

FIG. 55 is a side view of a patient interface shown on a patient's headaccording to an example of the present technology, the patient interfacebeing shown with the headgear strap assembly in a first adjustedposition, e.g., looser position. FIG. 56 is a side view of a patientinterface shown on a patient's head according to an example of thepresent technology, the patient interface being shown with the headgearstrap assembly in a second adjusted position, e.g., tighter position.

FIGS. 83A to 86B are various views showing the fitting, adjusting, andremoving of the patient interface 3000 according to an example of thepresent technology.

For example, in FIG. 83A, the patient begins fitting the patientinterface 3000 by holding the patient interface 3000 away from thepatient's nose ensuring that the positioning and stabilising structure3300 is curving or oriented upwards. This facilitates orientation andengagement of the seal-forming structure 3100 with respect to thepatient's nose and facilitates orientation and engagement of thepositioning and stabilising structure 3300 over the top of the patient'shead.

FIG. 83B shows the patient placing the cushion assembly 3075 and theseal-forming structure 3100 thereof under the patient's nose andensuring that it sits comfortably against the patient's face. Suchfigure also shows the patient beginning to don the positioning andstabilising structure 3300, i.e., by pulling a lower one of the backstrap portions 3344 a with one hand while holding the frame assembly3500/cushion assembly 3075 with the other hand to stretch the headgearstrap assembly 3330 over the patient's head. FIGS. 83C and 83D show theheadgear strap assembly 3330 stretched around the back of the patient'shead to hold the patient interface 3000 against the patient's nose,e.g., with an upper one of the back strap portions 3344 b sittingcomfortably on top of the patient's head.

As illustrated, one of the split back strap portions 3344 b ispositioned superior to the patient's occipital lobe while the other ofthe split back strap portions 3344 a is positioned inferior to thepatient's occipital lobe, e.g., to cup the back of the patient's headfor support and stability. However, it should be appreciated that theback strap portions 3344 a, 3344 b may be positioned in differentpositions along the back of the patient's head, e.g., to adjust tensionor position for patient preference and/or comfort. For example, as shownin FIGS. 55 and 56 , both back strap portions 3344 a, 3344 b may bepositioned more adjacent to one another towards a top of the patient'shead, e.g., both positioned generally superior to the patient'soccipital lobe. FIGS. 84A and 84B are exemplary views showing adjustmentof the split back strap portions 3344 a, 3344 b to achieve a comfortablefit, e.g., adjust the split back strap portions 3344 a, 3344 b byspreading them apart to loosen or draw them closer together to tighten.

If additional adjustment of the headgear strap assembly 3330 may berequired, adjustment may be conducted via the buckle 3360 as describedabove. For example, the headgear strap assembly 3330 may be tightened bypulling the free end of the back strap portions 3344 a, 3344 b (e.g.,via reinforcement portion or finger tab 3347) away from the buckle 3360as shown in FIG. 86A. The headgear strap assembly 3330 may be loosenedby gripping the strap portions on either side of the buckle 3360 andpulling as shown in FIG. 86B, or by pulling the buckle 3360 relative tothe strap portions.

It should be appreciated that the headgear strap assembly 3330 may beassembled to the patient interface 3000 so that the buckle 3360 can belocated on either the right-hand side of the patient's head or theleft-hand side of the patient's head, e.g., depending on patientpreference to facilitate adjustment while being worn. For example, itmay be preferable for the buckle 3360 to be located on the right-handside of the patient's head for a right-handed patient to facilitateright-handed adjustment of the buckle 3360 by the patient.

The patient interface 3000 is now fitted and ready for use, i.e., theshort tube 4180 of the patient interface 3000 may be connected to theair circuit 4170 for delivery of pressurised gas from the air circuit4170 to the patient interface 3000.

As shown in FIG. 85 , the patient interface 3000 may be removed bypulling the frame assembly 3500/cushion assembly 3075 along with theback strap portions 3344 a, 3344 b up and over the patient's head.

5.3.7 Vent

In one form, the patient interface 3000 includes a vent 3400 constructedand arranged to allow for the washout of exhaled gases, e.g. carbondioxide.

In certain forms the vent 3400 is configured to allow a continuous ventflow from an interior of the plenum chamber 3200 to ambient whilst thepressure within the plenum chamber is positive with respect to ambient.The vent 3400 is configured such that the vent flow rate has a magnitudesufficient to reduce rebreathing of exhaled CO₂ by the patient whilemaintaining the therapeutic pressure in the plenum chamber in use.

One form of vent 3400 in accordance with the present technologycomprises a plurality of holes, for example, about 2 or more holes,about 5 to about 50 holes, about 10 to about 40 holes, about 10 to about20 holes, about 20 to about 80 holes, or about 40 to about 60 holes, orabout 45 to about 55 holes.

The vent 3400 may be located in the plenum chamber 3200. Alternatively,the vent 3400 is located in a decoupling structure, e.g., a swivel.

FIGS. 4-24 illustrate a vent 3400 according to an example of the presenttechnology. In the illustrated example, the vent 3400 is provided to theframe assembly 3500, and the vent 3400 comprises diffusing members 3450,e.g., filter materials, along the vent flow path structured and arrangedto diffuse the exhaust vent flow to produce less noise. The diffusedvent flow also reduces or eliminates jetting to that vent flow will notjet onto the bed and/or a partner adjacent the patient interface.

As illustrated, the main body 3510 includes an interior surface 3512(along the posterior side) adapted to be oriented towards the interiorof the plenum chamber 3200 in use, i.e., the pressurizable volume, andan exterior surface 3514 (along the anterior side) adapted to beoriented towards atmosphere in use. A multi-hole vent arrangement 3515is provided to the main body 3510 on each side of the cover connectingportion 3540. Each multi-hole vent arrangement 3515 includes a pluralityof vent orifices 3516 extending through the main body 3510 from theinterior surface 3512 to the exterior surface 3514 to allow gas to bedischarged to atmosphere. The exterior surface 3514 forms a bottom ofthe recessed region 3550 in the anterior side of the main body 3510.

In the illustrated example, as best shown in FIGS. 21-22 , eachmulti-hole vent arrangement 3515 is arranged in an arc or U-shape withthe open end oriented towards the cover connecting portion 3540. Aspacer 3518, e.g., U-shaped protrusion, is provided to the exteriorsurface 3514 and extends along the interior periphery of a respectivemulti-hole vent arrangement 3515 to support a respective diffusingmember 3450. The spacer 3518 supports the diffusing member 3450 inspaced relation from the exterior surface 3514 and the outlet end ofeach of the vent orifices 3516, e.g., see FIG. 9 .

Also, a plurality of ribs 3560 are provided along the outer perimeter ofthe recessed region 3550, which provides spaced ribs 3560 along theouter periphery of each multi-hole vent arrangement 3515. In theillustrated example, each of the spaced ribs 3560 along the outerperiphery of each multi-hole vent arrangement 3515 includes a steppedconfiguration including a first, lower step 3561 and a second, upperstep 3562.

In the illustrated example, the first, lower step 3561 of each of thespaced ribs 3560 is structured and arranged to support the outer edge ofa respective diffusing member 3450. Accordingly, the spacer 3518 alongwith the first steps 3561 of the spaced ribs 3560 collectively form araised platform to support the diffusing member 3450 in spaced relationfrom the exterior surface 3514 and the outlet end of each of the ventorifices 3516, e.g., to minimize noise. Also, such spacing or offset ofthe diffusing member 3450 from the outlet end of each of the ventorifices 3516 creates an air gap, which ensures that the vent orifices3516 do not become occluded by the diffusing member 3450 at any time.

As noted above, the second, upper step 3562 of each of the spaced ribs3560 is structured and arranged to provide a stop for the outer edge ofthe anterior wall 3585 when the cover 3580 is connected to the main body3510. In an alternative example, the second, upper step 3562 of each ofthe spaced ribs may not be provided, e.g., see FIG. 58 which shows ribs3560 each including only a first step 3561.

When the cover 3580 is connected to the main body 3510, the anteriorwall 3585 is supported in spaced relation from the exterior surface 3514or bottom of the recessed region 3550 to accommodate and retain thediffusing member 3450 between the anterior wall 3585 and the spacer3518/first steps 3561, i.e., main body 3510 and cover 3580 form a casingor cartridge for the diffusing member 3450. Moreover, as describedbelow, the outer edge or outer periphery of the anterior wall 3585 isspaced from the outer edge or periphery of the recessed region 3550,such spacing or gap between the anterior wall 3585 and the periphery ofthe recessed region 3550 forming a vent outlet 3420 of the vent 3400.

As illustrated, each diffusing member 3450 is arranged to cover therespective multi-hole vent arrangement 3515 so that flow exiting thevent orifices 3516 of the multi-hole vent arrangement 3515 flows intothe diffusing member 3450. In an example, the diffusing member 3450 maybe constructed of a porous material that allows gas to flow through thematerial but diffuses any jet or other flow formation exiting the ventorifices 3516, e.g., non-woven fibrous material, woven fibrous material.In an example, the diffusing member 3450 may comprise a diffusingmaterial which may be similar to or the same as a filter material orfilter media. In an example, the diffusing member 3450 may comprise athickness of about 0.1-10 mm, e.g., 3-8 mm, 5-7 mm, 6-8 mm, e.g., 7 mm,however other suitable thicknesses are possible. In the illustratedexample, the diffusing member 3450 comprises a single layer, however itshould be appreciated that the diffusing member 3450 may comprise two ormore layers, e.g., stacked layers, of similar or dissimilar diffusingmaterials.

In an example, the cover 3580 is removably connected to the main body3510, e.g., to allow cleaning and/or replacement of the diffusingmembers 3450. Alternatively, the entire frame assembly 3500 may bereplaced, rather than replace the individual diffusing members 3450.

The main body 3510 and the cover 3580 cooperate to form a diffusionsection including a diffusion section inlet 3410 (i.e., the outlet endof each of the vent orifices 3516) and a diffusion section outlet 3420(i.e., gap between the anterior wall 3585 and the periphery of therecessed region 3550), the diffusion section outlet 3420 correspondingto a vent outlet of the vent 3400. As illustrated, the spaced ribs 3560are disposed within the diffusion section between the diffusion sectioninlet 3410 and the diffusion section outlet 3420 to divide vent flowaround the perimeter of the frame assembly 3500.

In the illustrated example, the spaced ribs 3560 are arranged to supportrespective diffusing members 3450 as well as divide vent flow. In theillustrated example, additional ribs 3565 may be provided along superiorand inferior sides of the cover connecting portion 3540. Such ribs 3565cooperate with the ribs 3560 to divide vent flow, however such ribs 3565are not arranged to support respective diffusing members 3450. In analternative example, such ribs 3565 may not be provided.

Also, in an alternative example, one or more ribs may be provided to thecover 3580. For example, one or more ribs on the cover 3580 maycooperate with one or more ribs provided to the main body 3510 to dividevent flow. In another example, one or more ribs may be provided to thecover 3580 in lieu of ribs provided to the main body 3510 to divide ventflow.

In an example, the one or more ribs may comprise an integral one-piececonstruction with the main body 3510 and/or the one or more ribs maycomprise an integral one-piece construction with the cover 3520, e.g.,one or more ribs molded in one-piece with the main body 3510 and/or thecover 3520. In an alternative example, the one or more ribs may beformed separately from the main body 3510 and assembled to the main body3510 in a separate process and/or the one or more ribs may be formedseparately from the cover 3520 and assembled to the cover 3520 in aseparate process, e.g., one or more ribs separately molded andindividually assembled to the main body 3510 and/or the cover 3520.However, it should be appreciated that the one or more ribs may beprovided to the vent in other suitable manners.

In the illustrated example (e.g., see FIG. 14 ), the spaced ribs 3560,3565 act as flow dividers that establish spaced and separated vent flowpaths V that divide or apportion exhaust vent flow around the peripheryof the frame assembly 3500 throughout the therapeutic pressure. That is,the spaced ribs 3560, 3565 are positioned and oriented with respect tothe diffusion section inlet 3410 and the diffusion section outlet 3420to divide the turbulent kinetic energy at the diffusion section inlet3410 (i.e., the outlet end of each of the vent orifices 3516) intosegments to optimize exhaust vent flow and minimize noise. In anexample, the spaced ribs 3560, 3565 may divide the turbulent kineticenergy into substantial equal segments so that the energy may beuniformly directed to the diffusion section outlet 3420, i.e., the ventoutlet of the vent 3400. However, it should be appreciated that thespaced ribs 3560, 3565 may divide flow into unequal and/or equalsegments.

It should be appreciated that the anterior wall 3585 forms a diffusionsection outlet 3420, i.e., vent outlet of the vent 3400, that is spacedradially outwardly of the vent inlet 3517 of the vent 3400 (i.e., theinlet end of each of the vent orifices 3516) and the diffusion sectioninlet 3410 (i.e., the outlet end of each of the vent orifices 3516).That is, vent flow cannot flow straight through the vent orifices 3516to the diffusion section outlet 3420, i.e., the vent outlet, and mustflow at least in part radially from the vent inlet 3517 to the ventoutlet 3420.

In use, the vent 3400 is provided to the patient interface 3000 to allowa flow of gas from an interior of the patient interface, e.g., theplenum chamber 3200, to an exterior of the patient interface 3000, e.g.,to atmosphere. The vent 3400 is structured and arranged to provide avent flow path that passes through the plurality of vent orifices 3516of each multi-hole vent arrangement 3515 into the diffusion section,through respective diffusing members 3450, and then through divided ventflow paths V provided by the spaced ribs 3560, 3565 to the vent outlet3420. In an example, all flow may not necessarily pass through thediffusing members 3450, e.g., at least some of the flow may bypass thediffusing members 3450 and flow directly from the vent orifices to thedivided vent flow paths provided by the spaced ribs to the vent outlet3420.

The vent 3400 is structured and arranged to improve diffusivity in ventflow to generate lower turbulent kinetic energy, and therefore lowernoise, e.g., to improve patient sleep quality. Diffusivity at leastpartly depends on air flow through vent holes and along the vent flowpath, and air velocity throughout the vent flow path. High air velocityhas high turbulent kinetic energy, and turbulent kinetic energy is anindicator for noise.

In the illustrated example, the vent 3400 provides several features togenerate the lower turbulent kinetic energy. For example, eachmulti-hole vent arrangement 3515 includes vent orifices 3516 structuredand arranged to prevent cross flow and allow substantially evendistribution of air flow volume into the diffusion section. The spacer3518 and spaced ribs 3560 support the diffusing member 3450 in spacedrelation the vent orifices 3516, e.g., to minimize noise and preventocclusion by the diffusing member 3450. Further, the spaced ribs 3560,3565 act as a flow separator to separate the exhaust flow for lowerturbulent kinetic energy.

Aspects of the vent 3400 may be tuned or optimized to provide a desiredflow-pressure curve within a therapeutic pressure range. In an example,one or more characteristics of aspects of the vent 3400 may be tuned,e.g., based on venting requirement, sound requirement, treatmentrequirement, etc.

For example, the shape, size, number, orientation, and spacingarrangement of the ribs 3560, 3565 may be optimized to regulate flow.

In an example, the number of ribs 3560, 3565 along the recessed regionmay change, e.g., as the size of the vent assembly changes and/or thenumber and size of the vent orifices changes. In an example, the spacingbetween ribs may be about 7-9 mm. In example, the frame assembly 3500may include 5-30 ribs, however other suitable numbers of ribs arepossible. For example, the frame assembly 3500 may include 10-20 ribs,8-15 ribs. In an example, 3-15 ribs (e.g., 5-10 ribs) may be associatedwith each multi-hole vent arrangement 3515.

In an example, the ribs 3560, 3565 may extend in a generallyorthogonal/tangential direction to the main body 3510 of the frameassembly 3500. For example, the ribs 3560, 3565 may extend in agenerally orthogonal direction to a major face (e.g., exterior surface3514) of the main body 3510. This orientation of the ribs may minimizeany dead space in the vent, e.g., compared to the ribs being oriented atan acute angle to the main body 3510. This orientation of the ribs mayalso help the airflow to exit the vent outlet 3420 (i.e., gap betweenthe anterior wall 3585 and the periphery of the recessed region) in adirection that is generally orthogonal to the general plane of the mainbody 3510, thereby directing the airflow away from the patient's face inuse.

In an example, each of the ribs 3560, 3565 includes a generally smallthickness, e.g., 1-2 mm, e.g., 1.2 mm. This smaller thickness maximizesthe venting space of the air, e.g., by creating wider vent flow paths.However, other suitable thicknesses are possible.

In an example, the shape, size, orientation, and number of vent orifices3516 for each multi-hole vent arrangement 3515 may be tuned. In anexample, each vent orifice is generally circular and may have a diameterin the range of about 0.7-1.2 mm, e.g., 1 mm. In an example, each ventorifice may include a taper or draft angle, e.g., each vent orifice maydecrease in diameter from the inlet end at the interior surface to theoutlet end at the exterior surface. In the illustrated example, eachmulti-hole vent arrangement 3515 includes 8 orifices, however othersuitable numbers of orifices are possible. For example, each multi-holevent arrangement 3515 may include 2-30 orifices, e.g., 5-20 orifices,5-10 orifices, 6-8 orifices.

In an example, the axis of the flow path through each of the ventorifices 3516 may be parallel or angled away from one another such thatcross-flow is avoided to prevent generation of additional noise.

In an example, the size of the anterior wall 3585 may be tuned to adjustthe size of the vent outlet 3420, i.e., gap between the anterior wall3585 and the periphery of the recessed region).

In an example, the thickness, material, and shape of each diffusingmember 3450 may be tuned. In an example, each diffusing member 3450 isshaped to cover the vent orifices 3516 of the respective multi-hole ventarrangement.

In an example, it should be appreciated that the tuning of one or moreparameters may be implemented in conjunction with one or more otherparameters of the vent 3400 to optimize diffusion and the reduction ofturbulent kinetic energy to reduce noise. For example, certain ratiosbetween parameters may be tuned to optimize diffusion. In an example,the size/number of ribs 3560, 3565 may be tuned in conjunction with thesize/number of vent orifices 3516. For example, an exemplary ratio ofthe number of ribs to the number of orifices may be 0.5 to 1.0, e.g.,0.6 to 0.8, however other suitable ratios are possible. In anotherexample, the size/number of ribs 3560, 3565 may be tuned in conjunctionwith overall dimensions of the patient interface 3000.

While the vent 3400 is described in relation to a nasal-cradle typepatient interface, it should be appreciated that one or more aspects ofthe vent 3400 may be applicable to other types of patient interface,e.g., nasal, full-face, nasal prong type patient interfaces.

In an example, the frame assembly 3500 and vent 3400 thereof shown inFIGS. 4-24 may comprise a frame/vent arrangement for single-patient,multi-use (SPMU) applications, e.g., for home use. In an example, analternative frame assembly may be provided to the patient interface formulti-patient, multi-use (MPMU) applications, e.g., for sleep lab orhospital uses.

FIGS. 76-82C illustrate a patient interface 6000 including a MPMU frameassembly 6500 according to an example of the present technology. In theillustrated example, the patient interface 6000 is substantially similarto patient interface 3000, but replaces frame assembly 3500 with frameassembly 6500 for MPMU applications. As illustrated, the frame assembly6500 also functions as a central hub to which the cushion assembly 3075,the positioning and stabilizing structure 3300, and the short tube 4180are connected, e.g., either in a removable fashion or a more permanentfashion.

In this example, the frame assembly 6500 is similar to frame assembly3500 but comprises a different vent arrangement. As illustrated, theframe assembly 6500 includes a vent 6400 that does not include adiffusion section as in vent 3400, only a multi-hole vent arrangement6515 provided to the main body 6510 on each side of the connection port3600. Such frame assembly 6500 provides structure that may be moreamenable to MPMU applications and requirements, e.g., facilitatecleaning/decontamination between uses, less parts, more rigid/durable towithstand repeated use.

Each multi-hole vent arrangement 6515 includes a plurality of ventorifices 6516 extending through the main body 6510 from the interiorsurface 6512 (adapted to be oriented towards the interior of the plenumchamber 3200 in use, i.e., the pressurizable volume) to the exteriorsurface 6514 (adapted to be oriented towards atmosphere in use) to allowgas to be discharged to atmosphere.

In the illustrated example, the vent orifices 6516 of each multi-holevent arrangement 6515 may be arranged in columns. As illustrated inFIGS. 81, 82A, and 82B, the exterior surface 6514 of the main body mayprovide spaced-apart (e.g., and generally parallel) surface areas 6525with a stepped layout, with the outlet end of vent orifices 6516 foreach column arranged along a respective one of the surface areas 6525.That is, the exterior surface 6514 of the main body may include ridgesor ribs 6524 that provide such stepped arrangement of surface areas6525. In the illustrated example, the ridges 6524 are arranged on eachside of the connection port 3600 such that the surface areas 6525progressively step down away from the connection port 3600, e.g.,elevation of the surface areas 6525 progressively decreases away fromthe connection port 3600. Such arrangement orients the axis of the flowpath through each of the vent orifices 6516 to be parallel or angledaway from one another such that cross-flow is avoided to prevent noise.In an example, the ridges or ribs 6524 may facilitate manufacturing(e.g., molding) of the frame assembly 6500 and vent 6400 thereof.

It should be appreciated each multi-hole vent arrangement 6515 mayinclude any suitable number of columns, e.g., 2-10 columns, 3-5 columns,and each column may include any suitable number of vent orifices, e.g.,1-20 vent orifices, 2-10 orifices, 2-5 orifices. Also, it should beappreciated that each multi-hole vent arrangement 6515 may include ventorifices arranged in alternative manners, e.g., rows, radially, random.

The shape, size, orientation, and number of vent orifices 6516 for eachmulti-hole vent arrangement 6515 may be tuned. In an example, each ventorifice is generally circular and may have a diameter in the range ofabout 0.7-1.2 mm, e.g., 1 mm. In an example, each vent orifice mayinclude a taper or draft angle, e.g., each vent orifice may decrease indiameter from the inlet end at the interior surface to the outlet end atthe exterior surface. In the illustrated example, each multi-hole ventarrangement 6515 includes 18 orifices, however other suitable numbers oforifices are possible. For example, each multi-hole vent arrangement6515 may include 2-40 orifices, e.g., 5-25 orifices, 10-20 orifices.

The short tube 4180 may be permanently or removably connected to theconnection port 3600. In an example, as shown FIG. 82C, the short tube4180 and the connection portion 3600 may include a snap or interferencefit assembly, e.g., cuff 4185 of the short tube 4180 includes aperipheral groove 4186 adapted to engage a peripheral bead 3605 alongthe interior of the connection port 3600. However, it should beappreciated that the short tube 4180 may be connected to the connectionport 3600 in other suitable manners, e.g., either in a removable fashionor a more permanent fashion.

Similar to frame assembly 3500, a pair of rigidizer arms 3302 of thepositioning and stabilising structure 3300 are connected to respectivesides of the frame assembly 6500 by a respective one of a pair offlexible joints 3305. The headgear strap assembly 3330 may be connectedto the rigidiser arms 3302 as described above.

Also, the frame assembly 6500 comprises a cushion connecting portion6530, similar to cushion connecting portion 3530 of frame assembly 3500,structured and arranged to releasably connect the cushion assembly 3075to the frame assembly 6500 as described above.

5.3.8 Decoupling Structure(s)

In one form the patient interface 3000 includes at least one decouplingstructure, for example, a swivel or a ball and socket.

5.3.9 Connection Port

Connection port 3600 allows for connection to the air circuit 4170.

5.3.10 Forehead Support

In one form, the patient interface 3000 includes a forehead support3700. For example, FIG. 3A shows a non-invasive patient interface 3000in accordance with one aspect of the present technology comprising aseal-forming structure 3100, a plenum chamber 3200, a positioning andstabilising structure 3300, a vent 3400, one form of connection port3600 for connection to air circuit 4170, and a forehead support 3700.

5.3.11 Anti-Asphyxia Valve

In one form, the patient interface 3000 includes an anti-asphyxia valve.

5.3.12 Ports

In one form of the present technology, a patient interface 3000 includesone or more ports that allow access to the volume within the plenumchamber 3200. In one form this allows a clinician to supply supplementaloxygen. In one form, this allows for the direct measurement of aproperty of gases within the plenum chamber 3200, such as the pressure.

5.4 Air Circuit

An air circuit 4170 in accordance with an aspect of the presenttechnology is a conduit or a tube constructed and arranged to allow, inuse, a flow of air to travel between two components such as RPT device4000 and the patient interface 3000.

In particular, the air circuit 4170 may be in fluid connection with theoutlet of the pneumatic block of the RPT device 4000 and the patientinterface. The air circuit may be referred to as an air delivery tube.In some cases there may be separate limbs of the circuit for inhalationand exhalation. In other cases a single limb is used.

In some forms, the air circuit 4170 may comprise one or more heatingelements configured to heat air in the air circuit, for example tomaintain or raise the temperature of the air. The heating element may bein a form of a heated wire circuit, and may comprise one or moretransducers, such as temperature sensors. In one form, the heated wirecircuit may be helically wound around the axis of the air circuit 4170.The heating element may be in communication with a controller such as acentral controller. One example of an air circuit 4170 comprising aheated wire circuit is described in U.S. Pat. No. 8,733,349, which isincorporated herewithin in its entirety by reference.

5.4.1 Oxygen Delivery

In one form of the present technology, supplemental oxygen may bedelivered to one or more points in the pneumatic path, such as upstreamof the pneumatic block, to the air circuit 4170 and/or to the patientinterface 3000.

5.5 Glossary

For the purposes of the present technology disclosure, in certain formsof the present technology, one or more of the following definitions mayapply. In other forms of the present technology, alternative definitionsmay apply.

5.5.1 General

Air: In certain forms of the present technology, air may be taken tomean atmospheric air, and in other forms of the present technology airmay be taken to mean some other combination of breathable gases, e.g.atmospheric air enriched with oxygen.

Ambient: In certain forms of the present technology, the term ambientwill be taken to mean (i) external of the treatment system or patient,and (ii) immediately surrounding the treatment system or patient.

For example, ambient humidity with respect to a humidifier may be thehumidity of air immediately surrounding the humidifier, e.g. thehumidity in the room where a patient is sleeping. Such ambient humiditymay be different to the humidity outside the room where a patient issleeping.

In another example, ambient pressure may be the pressure immediatelysurrounding or external to the body.

In certain forms, ambient (e.g., acoustic) noise may be considered to bethe background noise level in the room where a patient is located, otherthan for example, noise generated by an RPT device or emanating from amask or patient interface. Ambient noise may be generated by sourcesoutside the room.

Automatic Positive Airway Pressure (APAP) therapy: CPAP therapy in whichthe treatment pressure is automatically adjustable, e.g. from breath tobreath, between minimum and maximum limits, depending on the presence orabsence of indications of SDB events.

Continuous Positive Airway Pressure (CPAP) therapy: Respiratory pressuretherapy in which the treatment pressure is approximately constantthrough a respiratory cycle of a patient. In some forms, the pressure atthe entrance to the airways will be slightly higher during exhalation,and slightly lower during inhalation. In some forms, the pressure willvary between different respiratory cycles of the patient, for example,being increased in response to detection of indications of partial upperairway obstruction, and decreased in the absence of indications ofpartial upper airway obstruction.

Flow rate: The volume (or mass) of air delivered per unit time. Flowrate may refer to an instantaneous quantity. In some cases, a referenceto flow rate will be a reference to a scalar quantity, namely a quantityhaving magnitude only. In other cases, a reference to flow rate will bea reference to a vector quantity, namely a quantity having bothmagnitude and direction. Flow rate may be given the symbol Q. ‘Flowrate’ is sometimes shortened to simply ‘flow’ or ‘airflow’.

In the example of patient respiration, a flow rate may be nominallypositive for the inspiratory portion of a breathing cycle of a patient,and hence negative for the expiratory portion of the breathing cycle ofa patient. Total flow rate, Qt, is the flow rate of air leaving the RPTdevice. Vent flow rate, Qv, is the flow rate of air leaving a vent toallow washout of exhaled gases. Leak flow rate, Ql, is the flow rate ofleak from a patient interface system or elsewhere. Respiratory flowrate, Qr, is the flow rate of air that is received into the patient'srespiratory system.

Humidifier: The word humidifier will be taken to mean a humidifyingapparatus constructed and arranged, or configured with a physicalstructure to be capable of providing a therapeutically beneficial amountof water (H₂O) vapour to a flow of air to ameliorate a medicalrespiratory condition of a patient.

Leak: The word leak will be taken to be an unintended flow of air. Inone example, leak may occur as the result of an incomplete seal betweena mask and a patient's face. In another example leak may occur in aswivel elbow to the ambient.

Noise, conducted (acoustic): Conducted noise in the present documentrefers to noise which is carried to the patient by the pneumatic path,such as the air circuit and the patient interface as well as the airtherein. In one form, conducted noise may be quantified by measuringsound pressure levels at the end of an air circuit.

Noise, radiated (acoustic): Radiated noise in the present documentrefers to noise which is carried to the patient by the ambient air. Inone form, radiated noise may be quantified by measuring soundpower/pressure levels of the object in question according to ISO 3744.

Noise, vent (acoustic): Vent noise in the present document refers tonoise which is generated by the flow of air through any vents such asvent holes of the patient interface.

Patient: A person, whether or not they are suffering from a respiratorycondition.

Pressure: Force per unit area. Pressure may be expressed in a range ofunits, including cmH₂O, g-f/cm² and hectopascal. 1 cmH₂O is equal to 1g-f/cm² and is approximately 0.98 hectopascal. In this specification,unless otherwise stated, pressure is given in units of cmH₂O.

The pressure in the patient interface is given the symbol Pm, while thetreatment pressure, which represents a target value to be achieved bythe mask pressure Pm at the current instant of time, is given the symbolPt.

Respiratory Pressure Therapy (RPT): The application of a supply of airto an entrance to the airways at a treatment pressure that is typicallypositive with respect to atmosphere.

Ventilator: A mechanical device that provides pressure support to apatient to perform some or all of the work of breathing.

5.5.1.1 Materials

Silicone or Silicone Elastomer: A synthetic rubber. In thisspecification, a reference to silicone is a reference to liquid siliconerubber (LSR) or a compression moulded silicone rubber (CMSR). One formof commercially available LSR is SILASTIC (included in the range ofproducts sold under this trademark), manufactured by Dow Corning.Another manufacturer of LSR is Wacker. Unless otherwise specified to thecontrary, an exemplary form of LSR has a Shore A (or Type A) indentationhardness in the range of about 35 to about 45 as measured using ASTMD2240.

Polycarbonate: a thermoplastic polymer of Bisphenol-A Carbonate.

5.5.1.2 Mechanical Properties

Resilience: Ability of a material to absorb energy when deformedelastically and to release the energy upon unloading.

Resilient: Will release substantially all of the energy when unloaded.Includes e.g. certain silicones, and thermoplastic elastomers.

Hardness: The ability of a material per se to resist deformation (e.g.described by a Young's Modulus, or an indentation hardness scalemeasured on a standardised sample size).

-   -   ‘Soft’ materials may include silicone or thermo-plastic        elastomer (TPE), and may, e.g. readily deform under finger        pressure.    -   ‘Hard’ materials may include polycarbonate, polypropylene, steel        or aluminium, and may not e.g. readily deform under finger        pressure.

Stiffness (or rigidity) of a structure or component: The ability of thestructure or component to resist deformation in response to an appliedload. The load may be a force or a moment, e.g. compression, tension,bending or torsion. The structure or component may offer differentresistances in different directions.

Floppy structure or component: A structure or component that will changeshape, e.g. bend, when caused to support its own weight, within arelatively short period of time such as 1 second.

Rigid structure or component: A structure or component that will notsubstantially change shape when subject to the loads typicallyencountered in use. An example of such a use may be setting up andmaintaining a patient interface in sealing relationship with an entranceto a patient's airways, e.g. at a load of approximately 20 to 30 cmH₂Opressure.

As an example, an I-beam may comprise a different bending stiffness(resistance to a bending load) in a first direction in comparison to asecond, orthogonal direction. In another example, a structure orcomponent may be floppy in a first direction and rigid in a seconddirection.

5.5.2 Respiratory Cycle

Apnea: According to some definitions, an apnea is said to have occurredwhen flow falls below a predetermined threshold for a duration, e.g. 10seconds. An obstructive apnea will be said to have occurred when,despite patient effort, some obstruction of the airway does not allowair to flow. A central apnea will be said to have occurred when an apneais detected that is due to a reduction in breathing effort, or theabsence of breathing effort, despite the airway being patent. A mixedapnea occurs when a reduction or absence of breathing effort coincideswith an obstructed airway.

Breathing rate: The rate of spontaneous respiration of a patient,usually measured in breaths per minute.

Duty cycle: The ratio of inhalation time, Ti to total breath time, Ttot.

Effort (breathing): The work done by a spontaneously breathing personattempting to breathe.

Expiratory portion of a breathing cycle: The period from the start ofexpiratory flow to the start of inspiratory flow.

Flow limitation: Flow limitation will be taken to be the state ofaffairs in a patient's respiration where an increase in effort by thepatient does not give rise to a corresponding increase in flow. Whereflow limitation occurs during an inspiratory portion of the breathingcycle it may be described as inspiratory flow limitation. Where flowlimitation occurs during an expiratory portion of the breathing cycle itmay be described as expiratory flow limitation.

Types of flow limited inspiratory waveforms:

(i) Flattened: Having a rise followed by a relatively flat portion,followed by a fall.

(ii) M-shaped: Having two local peaks, one at the leading edge, and oneat the trailing edge, and a relatively flat portion between the twopeaks.

(iii) Chair-shaped: Having a single local peak, the peak being at theleading edge, followed by a relatively flat portion.

(iv) Reverse-chair shaped: Having a relatively flat portion followed bysingle local peak, the peak being at the trailing edge.

Hypopnea: According to some definitions, a hypopnea is taken to be areduction in flow, but not a cessation of flow. In one form, a hypopneamay be said to have occurred when there is a reduction in flow below athreshold rate for a duration. A central hypopnea will be said to haveoccurred when a hypopnea is detected that is due to a reduction inbreathing effort. In one form in adults, either of the following may beregarded as being hypopneas:

(i) a 30% reduction in patient breathing for at least 10 seconds plus anassociated 4% desaturation; or

(ii) a reduction in patient breathing (but less than 50%) for at least10 seconds, with an associated desaturation of at least 3% or anarousal.

Hyperpnea: An increase in flow to a level higher than normal.

Inspiratory portion of a breathing cycle: The period from the start ofinspiratory flow to the start of expiratory flow will be taken to be theinspiratory portion of a breathing cycle.

Patency (airway): The degree of the airway being open, or the extent towhich the airway is open. A patent airway is open. Airway patency may bequantified, for example with a value of one (1) being patent, and avalue of zero (0), being closed (obstructed).

Positive End-Expiratory Pressure (PEEP): The pressure above atmospherein the lungs that exists at the end of expiration.

Peak flow rate (Qpeak): The maximum value of flow rate during theinspiratory portion of the respiratory flow waveform.

Respiratory flow rate, patient airflow rate, respiratory airflow rate(Qr): These terms may be understood to refer to the RPT device'sestimate of respiratory flow rate, as opposed to “true respiratory flowrate” or “true respiratory flow rate”, which is the actual respiratoryflow rate experienced by the patient, usually expressed in litres perminute.

Tidal volume (Vt): The volume of air inhaled or exhaled during normalbreathing, when extra effort is not applied. In principle theinspiratory volume Vi (the volume of air inhaled) is equal to theexpiratory volume Ve (the volume of air exhaled), and therefore a singletidal volume Vt may be defined as equal to either quantity. In practicethe tidal volume Vt is estimated as some combination, e.g. the mean, ofthe inspiratory volume Vi and the expiratory volume Ve.

(inhalation) Time (Ti): The duration of the inspiratory portion of therespiratory flow rate waveform.

(exhalation) Time (Te): The duration of the expiratory portion of therespiratory flow rate waveform.

(total) Time (Ttot): The total duration between the start of oneinspiratory portion of a respiratory flow rate waveform and the start ofthe following inspiratory portion of the respiratory flow rate waveform.

Typical recent ventilation: The value of ventilation around which recentvalues of ventilation Vent over some predetermined timescale tend tocluster, that is, a measure of the central tendency of the recent valuesof ventilation.

Upper airway obstruction (UAO): includes both partial and total upperairway obstruction. This may be associated with a state of flowlimitation, in which the flow rate increases only slightly or may evendecrease as the pressure difference across the upper airway increases(Starling resistor behaviour).

Ventilation (Vent): A measure of a rate of gas being exchanged by thepatient's respiratory system. Measures of ventilation may include one orboth of inspiratory and expiratory flow, per unit time. When expressedas a volume per minute, this quantity is often referred to as “minuteventilation”. Minute ventilation is sometimes given simply as a volume,understood to be the volume per minute.

5.5.3 Ventilation

Adaptive Servo-Ventilator (ASV): A servo-ventilator that has achangeable, rather than fixed target ventilation. The changeable targetventilation may be learned from some characteristic of the patient, forexample, a respiratory characteristic of the patient.

Backup rate: A parameter of a ventilator that establishes the minimumbreathing rate (typically in number of breaths per minute) that theventilator will deliver to the patient, if not triggered by spontaneousrespiratory effort.

Cycled: The termination of a ventilator's inspiratory phase. When aventilator delivers a breath to a spontaneously breathing patient, atthe end of the inspiratory portion of the breathing cycle, theventilator is said to be cycled to stop delivering the breath.

Expiratory positive airway pressure (EPAP): a base pressure, to which apressure varying within the breath is added to produce the desired maskpressure which the ventilator will attempt to achieve at a given time.

End expiratory pressure (EEP): Desired mask pressure which theventilator will attempt to achieve at the end of the expiratory portionof the breath. If the pressure waveform template Π(Φ) is zero-valued atthe end of expiration, i.e. Π(Φ)=0 when Φ=1, the EEP is equal to theEPAP.

Inspiratory positive airway pressure (IPAP): Maximum desired maskpressure which the ventilator will attempt to achieve during theinspiratory portion of the breath.

Pressure support: A number that is indicative of the increase inpressure during ventilator inspiration over that during ventilatorexpiration, and generally means the difference in pressure between themaximum value during inspiration and the base pressure (e.g.,PS=IPAP−EPAP). In some contexts pressure support means the differencewhich the ventilator aims to achieve, rather than what it actuallyachieves.

Servo-ventilator: A ventilator that measures patient ventilation, has atarget ventilation, and which adjusts the level of pressure support tobring the patient ventilation towards the target ventilation.

Spontaneous/Timed (S/T): A mode of a ventilator or other device thatattempts to detect the initiation of a breath of a spontaneouslybreathing patient. If however, the device is unable to detect a breathwithin a predetermined period of time, the device will automaticallyinitiate delivery of the breath.

Swing: Equivalent term to pressure support.

Triggered: When a ventilator delivers a breath of air to a spontaneouslybreathing patient, it is said to be triggered to do so at the initiationof the respiratory portion of the breathing cycle by the patient'sefforts.

5.5.4 Anatomy

5.5.4.1 Anatomy of the Face

Ala: the external outer wall or “wing” of each nostril (plural: alar)

Alar angle:

Alare: The most lateral point on the nasal ala.

Alar curvature (or alar crest) point: The most posterior point in thecurved base line of each ala, found in the crease formed by the union ofthe ala with the cheek.

Auricle: The whole external visible part of the ear.

(nose) Bony framework: The bony framework of the nose comprises thenasal bones, the frontal process of the maxillae and the nasal part ofthe frontal bone.

(nose) Cartilaginous framework: The cartilaginous framework of the nosecomprises the septal, lateral, major and minor cartilages.

Columella: the strip of skin that separates the nares and which runsfrom the pronasale to the upper lip.

Columella angle: The angle between the line drawn through the midpointof the nostril aperture and a line drawn perpendicular to the Frankforthorizontal while intersecting subnasale.

Frankfort horizontal plane: A line extending from the most inferiorpoint of the orbital margin to the left tragion. The tragion is thedeepest point in the notch superior to the tragus of the auricle.

Glabella: Located on the soft tissue, the most prominent point in themidsagittal plane of the forehead.

Lateral nasal cartilage: A generally triangular plate of cartilage. Itssuperior margin is attached to the nasal bone and frontal process of themaxilla, and its inferior margin is connected to the greater alarcartilage.

Lip, lower (labrale inferius):

Lip, upper (labrale superius):

Greater alar cartilage: A plate of cartilage lying below the lateralnasal cartilage. It is curved around the anterior part of the naris. Itsposterior end is connected to the frontal process of the maxilla by atough fibrous membrane containing three or four minor cartilages of theala.

Nares (Nostrils): Approximately ellipsoidal apertures forming theentrance to the nasal cavity. The singular form of nares is naris(nostril). The nares are separated by the nasal septum.

Naso-labial sulcus or Naso-labial fold: The skin fold or groove thatruns from each side of the nose to the corners of the mouth, separatingthe cheeks from the upper lip.

Naso-labial angle: The angle between the columella and the upper lip,while intersecting subnasale.

Otobasion inferior: The lowest point of attachment of the auricle to theskin of the face.

Otobasion superior: The highest point of attachment of the auricle tothe skin of the face.

Pronasale: the most protruded point or tip of the nose, which can beidentified in lateral view of the rest of the portion of the head.

Philtrum: the midline groove that runs from lower border of the nasalseptum to the top of the lip in the upper lip region.

Pogonion: Located on the soft tissue, the most anterior midpoint of thechin.

Ridge (nasal): The nasal ridge is the midline prominence of the nose,extending from the Sellion to the Pronasale.

Sagittal plane: A vertical plane that passes from anterior (front) toposterior (rear). The midsagittal plane is a sagittal plane that dividesthe body into right and left halves.

Sellion: Located on the soft tissue, the most concave point overlyingthe area of the frontonasal suture.

Septal cartilage (nasal): The nasal septal cartilage forms part of theseptum and divides the front part of the nasal cavity.

Subalare: The point at the lower margin of the alar base, where the alarbase joins with the skin of the superior (upper) lip.

Subnasal point: Located on the soft tissue, the point at which thecolumella merges with the upper lip in the midsagittal plane.

Supramenton: The point of greatest concavity in the midline of the lowerlip between labrale inferius and soft tissue pogonion

5.5.4.2 Anatomy of the Skull

Frontal bone: The frontal bone includes a large vertical portion, thesquama frontalis, corresponding to the region known as the forehead.

Mandible: The mandible forms the lower jaw. The mental protuberance isthe bony protuberance of the jaw that forms the chin.

Maxilla: The maxilla forms the upper jaw and is located above themandible and below the orbits. The frontal process of the maxillaprojects upwards by the side of the nose, and forms part of its lateralboundary.

Nasal bones: The nasal bones are two small oblong bones, varying in sizeand form in different individuals; they are placed side by side at themiddle and upper part of the face, and form, by their junction, the“bridge” of the nose.

Nasion: The intersection of the frontal bone and the two nasal bones, adepressed area directly between the eyes and superior to the bridge ofthe nose.

Occipital bone: The occipital bone is situated at the back and lowerpart of the cranium. It includes an oval aperture, the foramen magnum,through which the cranial cavity communicates with the vertebral canal.The curved plate behind the foramen magnum is the squama occipitalis.

Orbit: The bony cavity in the skull to contain the eyeball.

Parietal bones: The parietal bones are the bones that, when joinedtogether, form the roof and sides of the cranium.

Temporal bones: The temporal bones are situated on the bases and sidesof the skull, and support that part of the face known as the temple.

Zygomatic bones: The face includes two zygomatic bones, located in theupper and lateral parts of the face and forming the prominence of thecheek.

5.5.4.3 Anatomy of the Respiratory System

Diaphragm: A sheet of muscle that extends across the bottom of the ribcage. The diaphragm separates the thoracic cavity, containing the heart,lungs and ribs, from the abdominal cavity. As the diaphragm contractsthe volume of the thoracic cavity increases and air is drawn into thelungs.

Larynx: The larynx, or voice box houses the vocal folds and connects theinferior part of the pharynx (hypopharynx) with the trachea.

Lungs: The organs of respiration in humans. The conducting zone of thelungs contains the trachea, the bronchi, the bronchioles, and theterminal bronchioles. The respiratory zone contains the respiratorybronchioles, the alveolar ducts, and the alveoli.

Nasal cavity: The nasal cavity (or nasal fossa) is a large air filledspace above and behind the nose in the middle of the face. The nasalcavity is divided in two by a vertical fin called the nasal septum. Onthe sides of the nasal cavity are three horizontal outgrowths callednasal conchae (singular “concha”) or turbinates. To the front of thenasal cavity is the nose, while the back blends, via the choanae, intothe nasopharynx.

Pharynx: The part of the throat situated immediately inferior to (below)the nasal cavity, and superior to the oesophagus and larynx. The pharynxis conventionally divided into three sections: the nasopharynx(epipharynx) (the nasal part of the pharynx), the oropharynx(mesopharynx) (the oral part of the pharynx), and the laryngopharynx(hypopharynx).

5.5.5 Patient Interface

Anti-asphyxia valve (AAV): The component or sub-assembly of a masksystem that, by opening to atmosphere in a failsafe manner, reduces therisk of excessive CO₂ rebreathing by a patient.

Elbow: An elbow is an example of a structure that directs an axis offlow of air travelling therethrough to change direction through anangle. In one form, the angle may be approximately 90 degrees. Inanother form, the angle may be more, or less than 90 degrees. The elbowmay have an approximately circular cross-section. In another form theelbow may have an oval or a rectangular cross-section. In certain formsan elbow may be rotatable with respect to a mating component, e.g. about360 degrees. In certain forms an elbow may be removable from a matingcomponent, e.g. via a snap connection. In certain forms, an elbow may beassembled to a mating component via a one-time snap during manufacture,but not removable by a patient.

Frame: Frame will be taken to mean a mask structure that bears the loadof tension between two or more points of connection with a headgear. Amask frame may be a non-airtight load bearing structure in the mask.However, some forms of mask frame may also be air-tight.

Functional dead space:

Headgear: Headgear will be taken to mean a form of positioning andstabilizing structure designed for use on a head. For example theheadgear may comprise a collection of one or more struts, ties andstiffeners configured to locate and retain a patient interface inposition on a patient's face for delivery of respiratory therapy. Someties are formed of a soft, flexible, elastic material such as alaminated composite of foam and fabric.

Membrane: Membrane will be taken to mean a typically thin element thathas, preferably, substantially no resistance to bending, but hasresistance to being stretched.

Plenum chamber: a mask plenum chamber will be taken to mean a portion ofa patient interface having walls at least partially enclosing a volumeof space, the volume having air therein pressurised above atmosphericpressure in use. A shell may form part of the walls of a mask plenumchamber.

Seal: May be a noun form (“a seal”) which refers to a structure, or averb form (“to seal”) which refers to the effect. Two elements may beconstructed and/or arranged to ‘seal’ or to effect ‘sealing’therebetween without requiring a separate ‘seal’ element per se.

Shell: A shell will be taken to mean a curved, relatively thin structurehaving bending, tensile and compressive stiffness. For example, a curvedstructural wall of a mask may be a shell. In some forms, a shell may befaceted. In some forms a shell may be airtight. In some forms a shellmay not be airtight.

Stiffener: A stiffener will be taken to mean a structural componentdesigned to increase the bending resistance of another component in atleast one direction.

Strut: A strut will be taken to be a structural component designed toincrease the compression resistance of another component in at least onedirection.

Swivel (noun): A subassembly of components configured to rotate about acommon axis, preferably independently, preferably under low torque. Inone form, the swivel may be constructed to rotate through an angle of atleast 360 degrees. In another form, the swivel may be constructed torotate through an angle less than 360 degrees. When used in the contextof an air delivery conduit, the sub-assembly of components preferablycomprises a matched pair of cylindrical conduits. There may be little orno leak flow of air from the swivel in use.

Tie (noun): A structure designed to resist tension.

Vent: (noun): A structure that allows a flow of air from an interior ofthe mask, or conduit, to ambient air for clinically effective washout ofexhaled gases. For example, a clinically effective washout may involve aflow rate of about 10 litres per minute to about 100 litres per minute,depending on the mask design and treatment pressure.

5.5.6 Shape of Structures

Products in accordance with the present technology may comprise one ormore three-dimensional mechanical structures, for example a mask cushionor an impeller. The three-dimensional structures may be bounded bytwo-dimensional surfaces. These surfaces may be distinguished using alabel to describe an associated surface orientation, location, function,or some other characteristic. For example a structure may comprise oneor more of an anterior surface, a posterior surface, an interior surfaceand an exterior surface. In another example, a seal-forming structuremay comprise a face-contacting (e.g. outer) surface, and a separatenon-face-contacting (e.g. underside or inner) surface. In anotherexample, a structure may comprise a first surface and a second surface.

To facilitate describing the shape of the three-dimensional structuresand the surfaces, we first consider a cross-section through a surface ofthe structure at a point, p. See FIG. 3B to FIG. 3F, which illustrateexamples of cross-sections at point p on a surface, and the resultingplane curves. FIGS. 3B to 3F also illustrate an outward normal vector atp. The outward normal vector at p points away from the surface. In someexamples we describe the surface from the point of view of an imaginarysmall person standing upright on the surface.

5.5.6.1 Curvature in One Dimension

The curvature of a plane curve at p may be described as having a sign(e.g. positive, negative) and a magnitude (e.g. 1/radius of a circlethat just touches the curve at p).

Positive curvature: If the curve at p turns towards the outward normal,the curvature at that point will be taken to be positive (if theimaginary small person leaves the point p they must walk uphill). SeeFIG. 3B (relatively large positive curvature compared to FIG. 3C) andFIG. 3C (relatively small positive curvature compared to FIG. 3B). Suchcurves are often referred to as concave.

Zero curvature: If the curve at p is a straight line, the curvature willbe taken to be zero (if the imaginary small person leaves the point p,they can walk on a level, neither up nor down). See FIG. 3D.

Negative curvature: If the curve at p turns away from the outwardnormal, the curvature in that direction at that point will be taken tobe negative (if the imaginary small person leaves the point p they mustwalk downhill). See FIG. 3E (relatively small negative curvaturecompared to FIG. 3F) and FIG. 3F (relatively large negative curvaturecompared to FIG. 3E). Such curves are often referred to as convex.

5.5.6.2 Curvature of Two Dimensional Surfaces

A description of the shape at a given point on a two-dimensional surfacein accordance with the present technology may include multiple normalcross-sections. The multiple cross-sections may cut the surface in aplane that includes the outward normal (a “normal plane”), and eachcross-section may be taken in a different direction. Each cross-sectionresults in a plane curve with a corresponding curvature. The differentcurvatures at that point may have the same sign, or a different sign.Each of the curvatures at that point has a magnitude, e.g. relativelysmall. The plane curves in FIGS. 3B to 3F could be examples of suchmultiple cross-sections at a particular point.

Principal curvatures and directions: The directions of the normal planeswhere the curvature of the curve takes its maximum and minimum valuesare called the principal directions. In the examples of FIG. 3B to FIG.3F, the maximum curvature occurs in FIG. 3B, and the minimum occurs inFIG. 3F, hence FIG. 3B and FIG. 3F are cross sections in the principaldirections. The principal curvatures at p are the curvatures in theprincipal directions.

Region of a surface: A connected set of points on a surface. The set ofpoints in a region may have similar characteristics, e.g. curvatures orsigns.

Saddle region: A region where at each point, the principal curvatureshave opposite signs, that is, one is positive, and the other is negative(depending on the direction to which the imaginary person turns, theymay walk uphill or downhill).

Dome region: A region where at each point the principal curvatures havethe same sign, e.g. both positive (a “concave dome”) or both negative (a“convex dome”).

Cylindrical region: A region where one principal curvature is zero (or,for example, zero within manufacturing tolerances) and the otherprincipal curvature is non-zero.

Planar region: A region of a surface where both of the principalcurvatures are zero (or, for example, zero within manufacturingtolerances).

Edge of a surface: A boundary or limit of a surface or region.

Path: In certain forms of the present technology, ‘path’ will be takento mean a path in the mathematical—topological sense, e.g. a continuousspace curve from f(0) to f(1) on a surface. In certain forms of thepresent technology, a ‘path’ may be described as a route or course,including e.g. a set of points on a surface. (The path for the imaginaryperson is where they walk on the surface, and is analogous to a gardenpath).

Path length: In certain forms of the present technology, ‘path length’will be taken to mean the distance along the surface from f(0) to f(1),that is, the distance along the path on the surface. There may be morethan one path between two points on a surface and such paths may havedifferent path lengths. (The path length for the imaginary person wouldbe the distance they have to walk on the surface along the path).

Straight-line distance: The straight-line distance is the distancebetween two points on a surface, but without regard to the surface. Onplanar regions, there would be a path on the surface having the samepath length as the straight-line distance between two points on thesurface. On non-planar surfaces, there may be no paths having the samepath length as the straight-line distance between two points. (For theimaginary person, the straight-line distance would correspond to thedistance ‘as the crow flies’.)

5.5.6.3 Space Curves

Space curves: Unlike a plane curve, a space curve does not necessarilylie in any particular plane. A space curve may be closed, that is,having no endpoints. A space curve may be considered to be aone-dimensional piece of three-dimensional space. An imaginary personwalking on a strand of the DNA helix walks along a space curve. Atypical human left ear comprises a helix, which is a left-hand helix,see FIG. 3Q. A typical human right ear comprises a helix, which is aright-hand helix, see FIG. 3R. FIG. 3S shows a right-hand helix. Theedge of a structure, e.g. the edge of a membrane or impeller, may followa space curve. In general, a space curve may be described by a curvatureand a torsion at each point on the space curve. Torsion is a measure ofhow the curve turns out of a plane. Torsion has a sign and a magnitude.The torsion at a point on a space curve may be characterised withreference to the tangent, normal and binormal vectors at that point.

Tangent unit vector (or unit tangent vector): For each point on a curve,a vector at the point specifies a direction from that point, as well asa magnitude. A tangent unit vector is a unit vector pointing in the samedirection as the curve at that point. If an imaginary person were flyingalong the curve and fell off her vehicle at a particular point, thedirection of the tangent vector is the direction she would betravelling.

Unit normal vector: As the imaginary person moves along the curve, thistangent vector itself changes. The unit vector pointing in the samedirection that the tangent vector is changing is called the unitprincipal normal vector. It is perpendicular to the tangent vector.

Binormal unit vector: The binormal unit vector is perpendicular to boththe tangent vector and the principal normal vector. Its direction may bedetermined by a right-hand rule (see e.g. FIG. 3P), or alternatively bya left-hand rule (FIG. 3O).

Osculating plane: The plane containing the unit tangent vector and theunit principal normal vector. See FIGS. 3O and 3P.

Torsion of a space curve: The torsion at a point of a space curve is themagnitude of the rate of change of the binormal unit vector at thatpoint. It measures how much the curve deviates from the osculatingplane. A space curve which lies in a plane has zero torsion. A spacecurve which deviates a relatively small amount from the osculating planewill have a relatively small magnitude of torsion (e.g. a gently slopinghelical path). A space curve which deviates a relatively large amountfrom the osculating plane will have a relatively large magnitude oftorsion (e.g. a steeply sloping helical path). With reference to FIG.3S, since T2>T1, the magnitude of the torsion near the top coils of thehelix of FIG. 3S is greater than the magnitude of the torsion of thebottom coils of the helix of FIG. 3S

With reference to the right-hand rule of FIG. 3P, a space curve turningtowards the direction of the right-hand binormal may be considered ashaving a right-hand positive torsion (e.g. a right-hand helix as shownin FIG. 3S). A space curve turning away from the direction of theright-hand binormal may be considered as having a right-hand negativetorsion (e.g. a left-hand helix).

Equivalently, and with reference to a left-hand rule (see FIG. 3O), aspace curve turning towards the direction of the left-hand binormal maybe considered as having a left-hand positive torsion (e.g. a left-handhelix). Hence left-hand positive is equivalent to right-hand negative.See FIG. 3T.

5.5.6.4 Holes

A surface may have a one-dimensional hole, e.g. a hole bounded by aplane curve or by a space curve. Thin structures (e.g. a membrane) witha hole, may be described as having a one-dimensional hole. See forexample the one dimensional hole in the surface of structure shown inFIG. 3I, bounded by a plane curve.

A structure may have a two-dimensional hole, e.g. a hole bounded by asurface. For example, an inflatable tyre has a two dimensional holebounded by the interior surface of the tyre. In another example, abladder with a cavity for air or gel could have a two-dimensional hole.See for example the cushion of FIG. 3L and the example cross-sectionstherethrough in FIG. 3M and FIG. 3N, with the interior surface boundinga two dimensional hole indicated. In a yet another example, a conduitmay comprise a one-dimension hole (e.g. at its entrance or at its exit),and a two-dimension hole bounded by the inside surface of the conduit.See also the two dimensional hole through the structure shown in FIG.3K, bounded by a surface as shown.

5.6 Other Remarks

Unless the context clearly dictates otherwise and where a range ofvalues is provided, it is understood that each intervening value, to thetenth of the unit of the lower limit, between the upper and lower limitof that range, and any other stated or intervening value in that statedrange is encompassed within the technology. The upper and lower limitsof these intervening ranges, which may be independently included in theintervening ranges, are also encompassed within the technology, subjectto any specifically excluded limit in the stated range. Where the statedrange includes one or both of the limits, ranges excluding either orboth of those included limits are also included in the technology.

Furthermore, where a value or values are stated herein as beingimplemented as part of the technology, it is understood that such valuesmay be approximated, unless otherwise stated, and such values may beutilized to any suitable significant digit to the extent that apractical technical implementation may permit or require it.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this technology belongs. Although any methods andmaterials similar or equivalent to those described herein can also beused in the practice or testing of the present technology, a limitednumber of the exemplary methods and materials are described herein.

When a particular material is identified as being used to construct acomponent, obvious alternative materials with similar properties may beused as a substitute. Furthermore, unless specified to the contrary, anyand all components herein described are understood to be capable ofbeing manufactured and, as such, may be manufactured together orseparately.

It must be noted that as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include their plural equivalents,unless the context clearly dictates otherwise.

All publications mentioned herein are incorporated herein by referencein their entirety to disclose and describe the methods and/or materialswhich are the subject of those publications. The publications discussedherein are provided solely for their disclosure prior to the filing dateof the present application. Nothing herein is to be construed as anadmission that the present technology is not entitled to antedate suchpublication by virtue of prior invention. Further, the dates ofpublication provided may be different from the actual publication dates,which may need to be independently confirmed.

The terms “comprises” and “comprising” should be interpreted asreferring to elements, components, or steps in a non-exclusive manner,indicating that the referenced elements, components, or steps may bepresent, or utilized, or combined with other elements, components, orsteps that are not expressly referenced.

The subject headings used in the detailed description are included onlyfor the ease of reference of the reader and should not be used to limitthe subject matter found throughout the disclosure or the claims. Thesubject headings should not be used in construing the scope of theclaims or the claim limitations.

Although the technology herein has been described with reference toparticular examples, it is to be understood that these examples aremerely illustrative of the principles and applications of thetechnology. In some instances, the terminology and symbols may implyspecific details that are not required to practice the technology. Forexample, although the terms “first” and “second” may be used, unlessotherwise specified, they are not intended to indicate any order but maybe utilised to distinguish between distinct elements. Furthermore,although process steps in the methodologies may be described orillustrated in an order, such an ordering is not required. Those skilledin the art will recognize that such ordering may be modified and/oraspects thereof may be conducted concurrently or even synchronously.

It is therefore to be understood that numerous modifications may be madeto the illustrative examples and that other arrangements may be devisedwithout departing from the spirit and scope of the technology.

5.7 Reference Signs List

Feature Item Number patient 1000 bed partner 1100 patient interface 3000cushion assembly 3075 naris openings 3102 bridge portion 3104 lateralsupport regions 3108 mid - lateral regions 3110 medial region 3114thickened portion 3120 thickened portion 3121 thickened portion 3122frame connection structure 3150 seal connecting portion 3160 frameconnecting portion 3170 undercut 3175 recess 3177 cut-out 3179 plenumchamber 3200 chord 3210 superior point 3220 inferior point 3230positioning and stabilising structure 3300 rigidizer arms 3302 flexiblejoints 3305 headgear strap assembly 3330 strap 3340 side strap portion3342 button - hole 3343 back strap portion 3344 finger tab 3345 fingertab 3347 strap 3350 side strap portion 3352 button - hole 3353 fingertab 3355 buckle 3360 main body 3362 first end portion 3364 second endportion 3366 first opening 3370 surface 3375 cross - bar 3380 cross -bar 3382 base 3390 overmold 3391 vent 3400 diffusion section inlet 3410diffusion section outlet/vent outlet 3420 diffusing members 3450 frameassembly 3500 main body 3510 recess 3511 interior surface 3512 exteriorsurface 3514 multi - hole vent arrangement 3515 vent orifices 3516 ventinlet 3517 spacer 3518 body portion 3520 cushion connecting portion 3530undercut 3535 protrusion 3537 cover connecting portion 3540 bead 3545recessed region 3550 ribs 3560 first step 3561 second step 3562 ribs3565 protrusion 3577 cover 3580 protrusion 3581 anterior wall 3585 tubeportion 3590 groove 3595 connection port 3600 bead 3605 interfacingsurface 3615 forehead support 3700 sealing lip 3850 RPT device 4000 aircircuit 4170 short tube 4180 cuff 4185 groove 4186 humidifier 5000 backstrap portion  3344a back strap portion  3344b opening  3372a opening 3372b patient interface 6000 vent 6400 frame assembly 6500 main body6510 interior surface 6512 exterior surface 6514 multi-hole ventarrangement 6515 vent orifices 6516 ridge 6524 surface area 6525 cushionconnecting portion 6530

The invention claimed is:
 1. A patient interface to deliver a flow ofair at a positive pressure with respect to ambient air pressure to anentrance to the patient's airways including at least the entrance of apatient's nares while the patient is sleeping, to ameliorate sleepdisordered breathing, the patient interface comprising: a frameassembly; and a cushion assembly configured to removably and repeatablyconnect to the frame assembly, wherein the frame assembly and thecushion assembly form at least part of a plenum chamber pressurizable toa therapeutic pressure, wherein the cushion assembly comprises aone-piece construction including a seal-forming structure constructedand arranged to form a seal with a region of a patient's facesurrounding the entrance to the patient's airways and a frame connectionstructure constructed and arranged to removably and repeatably connectthe cushion assembly to the frame assembly, wherein the seal-formingstructure comprises a first elastomeric material and the frameconnection structure comprise a second elastomeric material, wherein thefirst elastomeric material comprises a first Shore A durometer and thesecond elastomeric material comprises a second Shore A durometer,wherein the second Shore A durometer is higher than the first Shore Adurometer, wherein the frame connection structure comprises an undercutthat acts as an interface or catch adapted to connect to the frameassembly, wherein the frame connection structure is arranged along aninterior surface or interior periphery of the seal-forming structuresuch that the frame connection structure and the undercut thereof isarranged or oriented towards an interior of the cushion assembly thatforms at least a portion of the plenum chamber, wherein the cushionassembly further comprises a flexible sealing flap provided to theseal-forming structure and comprising the first elastomeric material,wherein the flexible sealing flap is configured and arranged to form aseal with the frame assembly when the cushion assembly is connected tothe frame assembly, wherein the flexible sealing flap is arranged inwardof the frame connection structure within the plenum chamber, and whereinthe flexible sealing flap protrudes further from the interior peripheryinto the plenum chamber than the frame connection structure.
 2. Thepatient interface according to claim 1, wherein the seal-formingstructure comprises a nasal cradle cushion adapted to from a sealagainst at least an underside of the patient's nose.
 3. The patientinterface according to claim 1, wherein the seal-forming structure andthe frame connection structure comprise an overmolded construction toform a one-piece integrated component.
 4. The patient interfaceaccording to claim 3, wherein the frame connection structure comprises abase mold and the seal-forming structure comprises an overmold providedto the base mold.
 5. The patient interface according to claim 1, whereineach of the first elastomeric material and the second elastomericmaterial comprises a TPE or silicone material.
 6. The patient interfaceaccording to claim 1, wherein the frame connection structure comprisesone or more interfacing surfaces structured to bond with theseal-forming structure.
 7. The patient interface according to claim 1,wherein the first Shore A durometer is in the range of 30-50 Shore A andthe second Shore A durometer is in the range of 60-90 Shore A.
 8. Thepatient interface according to claim 1, wherein the frame assembly isrelatively harder than the frame connection structure.
 9. The patientinterface according to claim 1, wherein the frame connection structureand the undercut thereof extend around the entire perimeter or interiorperiphery of the seal-forming structure.
 10. The patient interfaceaccording to claim 1, wherein the frame connection structure comprisesone or more interfacing surfaces configured to engage the interiorsurface of the seal-forming structure.
 11. The patient interfaceaccording to claim 1, wherein the frame connection structure comprises aseparate and distinct part from the seal-forming structure that isconnected to the seal-forming structure to form the cushion assembly.12. The patient interface according to claim 1, wherein the flexiblesealing flap and the undercut of the frame connection structure form aspace therebetween to receive a portion of the frame assembly.
 13. Thepatient interface according to claim 12, wherein the frame assemblycomprises a barbed end, wherein the undercut of the frame connectionstructure is configured and arranged to engage behind the barbed endwhen the cushion assembly is connected to the frame assembly, andwherein the barbed end forms the portion of the frame assembly such thatthe barbed end is received in the space between the flexible sealingflap and the undercut when the cushion assembly is connected to theframe assembly.
 14. The patient interface according to claim 13, whereinthe barbed end comprises a tapered or angled leading surface, andwherein the tapered or angled leading surface is configured to guide andfacilitate outward deflection the frame connection structure over andbehind the barbed end.
 15. The patient interface according to claim 1,wherein the frame connection structure and the seal-forming structurecomprise different surface finishes.
 16. The patient interface accordingto claim 1, wherein the flexible sealing flap is configured and arrangedto engage and resiliently deflect against the frame assembly to form theseal.
 17. The patient interface according to claim 16, wherein theflexible sealing flap is configured and arranged such that, when theplenum chamber is pressurized to the therapeutic pressure, the flexiblesealing flap is urged with greater force against the frame assembly tostrengthen and increase sealing force between the flexible sealing flapand the frame assembly.
 18. The patient interface according to claim 1,wherein the flexible sealing flap includes a length that varies alongone or more portions of a perimeter of the seal-forming structure. 19.The patient interface according to claim 18, wherein the length of theflexible sealing flap at lateral sides of the seal-forming structure islonger than the length of the flexible sealing flap at superior andinferior sides of the seal-forming structure.
 20. A CPAP system forproviding gas at positive pressure for respiratory therapy to a patient,the CPAP system comprising: an RPT device configured to supply a flow ofgas at a therapeutic pressure; a patient interface according to claim 1;and an air delivery conduit configured to pass the flow of gas at thetherapeutic pressure from the RPT device to the patient interface.